Pharma News
Alvotech acquires Xbrane
On 20 March 2025, Alvotech announced the acquisition of Sweden’s Xbrane Biopharma AB’s (Xbrane) R & D operations and a biosimilar candidate XB003, a biosimilar to Cimzia (certolizumab pegol).
Colombia boosts health sovereignty through public-private biotech collaboration agreement
On 27 February 2025, Colombia's Ministry of Health, the National Institute of Health, and VaxThera announced a pivotal agreement to enhance research, development, and production of biologicals and health technologies. This collaboration aims to strengthen health sovereignty, advance biotechnology, and improve emergency response capabilities.
Bio-Thera partners with Tabuk in Saudi Arabia and SteinCares in LATAM
Bio-Thera Solutions (Bio-Thera) has partnered with Tabuk Pharmaceutical Manufacturing (Tabuk) to exclusively manufacture, distribute, and market BAT2206, a biosimilar to Stelara (ustekinumab), in Saudi Arabia. Simultaneously, Bio-Thera expanded its collaboration with SteinCares, granting exclusive rights to distribute an additional biosimilar in Latin America, reinforcing its global biosimilar strategy.
Klinge-Teva and MS Pharma agreements for Eylea and Stelara biosimilars in Europe and MENA
Klinge Biopharma (Klinge) and Teva Pharmaceuticals (Teva) formed a semi-exclusive agreement for the commercialization of Formycon’s FYB203 biosimilar to Eylea (aflibercept) in Europe, while MS Pharma partners for the MENA (Middle East and North Africa) commercialization of FYB202, a biosimilar to Stelara (ustekinumab).
Biosimilars thrive as China’s biotech industry gains momentum
China is emerging as a global biotech leader, attracting significant investment and partnerships from multinational pharmaceutical companies. Its innovative therapies and biosimilars are gaining international traction, reshaping the industry despite ongoing challenges.
Greener Pharmaceuticals: WHO's call for innovative regulatory practices and eco-friendly innovations
The World Health Organization (WHO) has launched the ‘Greener Pharmaceuticals’ Regulatory Highway’ initiative to promote sustainability in the pharmaceutical sector. The initiative calls for innovative regulatory practices, sustainable manufacturing, and eco-friendly innovations to reduce the environmental impact of healthcare products.
Coherus exits the biosimilars market with sale of Udenyca to Intas Pharmaceuticals
On 3 December 2024, Coherus BioSciences announced that it will sell its Udenyca (pegfilgrastim) franchise, a biosimilar version of Amgen’s Neulasta, to India-based drugmaker Intas Pharmaceuticals.
Meitheal expands portfolio with three biosimilars through exclusive US licensing agreement
On 31 October 2024, it was announced that Chicago-based Meitheal Pharmaceuticals had expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co, to market and distribute three biosimilars in the US. These include the oncology biosimilars pegfilgrastim and filgrastim, as well as fertility treatment follitropin alpha.
EMS proposes merger with Hypera to form Brazil's largest drugmaker
On 21 October 2024, Brazilian pharmaceutical giant EMS proposed a partnership with competitor Hypera Pharma, setting a course to become Brazil’s largest drug manufacturer.
Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206
In October 2024, China based Bio-Thera Solutions (Bio-Thera) and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Johnson & Johnson’s Stelara (ustekinumab).
Advances for Biocon Biologics’ Stelara and Eylea biosimilars
Biocon Biologics (Biocon) settled patent disputes with Janssen to commercialize Bmab 1200, a biosimilar of Stelara (ustekinumab), in several markets, including Europe and Canada. Additionally, Biocon received UK marketing authorization for Yesafili, its biosimilar of Eylea (aflibercept).
China’s Hasten Biopharma acquires 14 products from Celltrion
In July 2024, it was announced that China’s Hasten Biopharmaceutical has acquired the asset rights of 14 branded products across Pan-Asia countries and regions from Korea’s Celltrion.
Coherus sells adalimumab biosimilar Yusimry to HKF for US$40 million amid oncology focus
On 27 June 2024, Coherus BioSciences announced that is has divested Yusimry (aflibercept-jbvf), an adalimumab biosimilar to AbbVie’s rheumatoid arthritis therapy Humira, to Hong Kong King-Friend Industrial (HKF) in a US$40 million deal.
Biocon and Biomm forge alliance to bring semaglutide diabetes treatment to Brazil
By mid-April 2024, India-based Biocon Biologics signed an exclusive licensing and supply agreement that will allow Brazil’s Biomm SA to commercialise semaglutide, which is used to control type-2 diabetes in adults and has been repurposed for obesity management.
Klinge–MS Pharma and Teva–mAbxience biosimilars licence agreements
In May 2024, Klinge Biopharma announced an exclusive licensing and supply agreement with MS Pharma for FYB203 commercialization in the Middle East and North Africa (MENA) region. Previously, in April 2024, mAbxience and Teva Pharmaceuticals signed a strategic licensing agreement for a biosimilar candidate for oncology treatment.
Celltrion wins Peruvian public tenders for biosimilar infliximab and trastuzumab
In early May 2024, Celltrion reported that two of its biosimilar products, infliximab and trastuzumab, won the public tender in Peru, further expanding their prescription availability in Peru and solidifying their position in the broader Latin American pharmaceutical market.
Bio-Thera and SteinCares sign agreement to market two biosimilars in LATAM
Bio-Thera Solutions (Bio-Thera) announced in March 2024 a licensing agreement with SteinCares to market two biosimilars in Brazil and the rest of the region.
Formycon launches biosimilar ranibizumab Ravegza in Saudi, Gedeon Richter invests
In March 2024, Formycon and MS Pharma announced that their FYB201/ranibizumab Ravegza, a biosimilar to Lucentis, has received marketing authorization from the Saudi Food and Drug Authority.
mAbxience and Biosidus sign an agreement to manufacture Agalsidase Beta
mAbxience announced in February 2024 a pivotal agreement with Biosidus to manufacture Agalsidase Beta. This joint effort is expected to have a significant impact on the lives of patients affected by Fabry disease.
Biosimilars lawsuits and settlement updates for Regeneron and Alvotech
In January 2024, Regeneron filed a lawsuit against Amgen in the federal court in Los Angeles, alleging Amgen's proposed biosimilar of Regeneron's Eylea (aflibercept) violates patent rights. Additionally, in February 2024, Iceland-based Alvotech announced the anticipated global market entry dates for AVT04, a ustekinumab biosimilar to Stelara, following its settlement with Johnson & Johnson.
The journey of Pectuna pertuzumab follow-on biological in Iran
Pertuzumab is a monoclonal antibody (mAb) that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation. It is a pivotal therapeutic in oncology, targeting the overexpressed HER2 protein, particularly in breast cancer [1].
Sandoz US acquisition of ranibizumab biosimilar from Coherus
On 22 January 2024, it was announced that in the US, Sandoz will acquire ranibizumab biosimilar Cimerli (ranibizumab) from Coherus BioSciences.
Fiocruz and Pfizer sign agreement for generic of Xeljanz
Farmanguinhos/Fiocruz, the Institute of Drug Technology in Brazil, has signed a technology transfer agreement with Pfizer Brazil for the manufacturing of tofacitinib citrate, a generic counterpart to Xeljanz.
Biocon to commercialize biosimilars in 31 European countries
Biocon Biologics has successfully integrated Viatris’ biosimilars business in 31 European countries, it was announced in late November 2023.
J&J lawsuits settled over ustekinumab biosimilars
Johnson & Johnson (J&J), the maker of Stelara (ustekinumab), settled two lawsuits, one against Amgen, and the other against Alvotech and Teva Pharmaceuticals. Both lawsuits were over proposed ustekinumab biosimilars for the treatment of autoimmune conditions. These were settled in May and June 2023, respectively.
Genfar: Eurofarma's new generic brand in Latin America
Eurofarma announced on 29 September 2023 that it completed the acquisition of Laboratorios Genfar. Genfar is a generic drug company owned by the French company Sanofi, with offices in Colombia, Ecuador, and Peru.
Phase III trial results of CinnaGen’s ocrelizumab similar biotherapeutic product
Ocrelizumab is a therapeutic monoclonal antibody (mAb) that represents a different scientific approach to treating multiple sclerosis (MS). It is a humanized anti-CD20 mAb that targets CD20 marker on B lymphocytes, a typo of immune cell that plays a key role in the disease and serves as an immunosuppressive drug. Ocrelizumab binds selectively to CD20, which is expressed on the membrane of B cells. When ocrelizumab binds to CD20 on B cells, these cells are eliminated by antibody-dependent cell-mediated cytotoxicity and, to a lesser extent, complement-dependent cytotoxicity.
Insulin biosimilars: new CRL for Biocon, new deal for Meitheal/Tonghua Dongbao
In a dynamic landscape of pharmaceutical developments, Biocon Biologics (Biocon) faces a regulatory hurdle with a complete response letter from the US Food and Drug Administration (FDA), while Meitheal Pharmaceuticals expands its reach through a strategic licensing agreement with Tonghua Dongbao Pharmaceutical.
Abbott and mAbxience partnership for biosimilars in emerging markets
Abbott and mAbxience announced on 20 September 2023 that they had entered into a strategic partnership to commercialize several biosimilars in Latin America and other emerging markets.
Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership
In August 2023, Fresenius Kabi and Formycon announced that they have entered into a settlement agreement with Johnson & Johnson (J&J) concerning FYB202, a proposed ustekinumab biosimilar in the US. This followed the late July 2023 news that Alvotech and Teva Pharmaceuticals (Teva) have agreed to expand their existing strategic partnership agreement.
Cuba and China strengthen ties in biotechnology
The biotechnological cooperation between Cuba and China has been a longstanding relationship in the scientific and technological realms. For the benefit of both countries, Havana and Beijing have undertaken various collaborations in the field of biotechnology, driven by their bilateral relations and shared interest in the development of the healthcare and pharmaceutical industry.
New BioFactura-CuraTeQ partnership for ustekinumab biosimilar
CuraTeQ Biologics Private Limited, a subsidiary of India’s Aurobindo Pharma Limited, has entered into an exclusive license agreement to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (ustekinumab).
Four drugmakers sue the US government over the Inflation Reduction Act
In July 2023, Johnson & Johnson became the fourth large drugmaker to sue the US government over drug price negotiations in the Inflation Reduction Act (IRA). They join, Merck, Bristol Myers Squibb and Astellas in claiming that price negotiations by Medicare violate the First and Fifth Amendments of the US Constitution.
Celltrion–Rani partnership for RaniPill biosimilars
Celltrion and Rani Therapeutics (Rani) have entered a partnership under which Celltrion will supply ustekinumab and adalimumab biosimilars for RaniPill products under an exclusive license and supply agreement.
Cuba strengthens biotech industry through Eurasian partnerships
Cuba is consolidating its position in the field of biotechnology thanks to cooperation with several Eurasian nations, in particular Russia and Belarus.
Biosimilars manufacturing facilities approved by EU and US
Two biological drugs manufacturing facilities for biosimilar epoetin alfa and biosimilar bevacizumab were approved in the US and Europe in May and April 2023, respectively.
Cuba and China strengthen scientific cooperation for the development of medical treatments
In recent years, Cuba and China have established agreements to develop innovative medical treatments, notably Center for Genetic Engineering and Biotechnology (Centro de Ingeniería Genética y Biotecnología, CIGB) and Center for Molecular Immunology (Centro de Inmunología Molecular, CIM), and have shared their experiences in the field of medical research.
HK inno.N–mAbxience partnership in Korea and Coherus advances in the US
In early 2023, it was announced that South Korea’s HK inno.N signed an exclusive license agreement with Spain's mAbxience to bring a denosumab biosimilar to market in South Korea. In addition, in the US, Coherus BioSciences is to acquire exclusive commercial rights to Formycon’s under-development Eylea (aflibercept) biosimilar.
Global marketing and commercialization advances for Alvotech and partners
In late 2022 and early 2023, Alvotech announced several strategic partnership advances to further their global reach as a biotech company specializing in the development and manufacture of biosimilar medicines.
New partnerships: Biocon-Yoshindo and Syna-Intas
Biocon Biologics announced on 17 October 2022 that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo for commercializing two of its pipeline biosimilar assets in Japan. Following this, on 2 November 2022, Syna Therapeutics signed an exclusive license agreement with Intas to commercialize a haematology biosimilar.
New funding to strengthen Cuba's biopharmaceutical industry
On 22 September 2022, the United Nations Development Programme (UNDP) announced the execution of a loan of Euros 46.7 million (US$45.25 million dollars) to support Cuba's biopharmaceutical industry and improve the country's capacity to respond against diseases such as COVID-19.
Similis-Blau biosimilars development partnership announced
On 25 October 2022, JSR Life Sciences (and LLC (JSR)) have announced that their recently launched biosimilars development branch, Similis Bio, has signed a development and license agreement with Brazilian firm, Blau Farmacêutica.
GaBI news digest for 14 October 2022
Selected news for the week of 14 October 2022 for GaBI readers.
FDA inspections in Iceland and Singapore for Alvotech and Strides
On 5 September 2022, Alvotech announced that it had received communication from the US Food and Drug Administration (FDA) that detailed the assessment of their Icelandic manufacturing facility and Alvotech’s subsequent written responses to FDA. This followed Strides announced the successful FDA inspection of their Singapore facility in early August 2022.
Novartis is set to spin-off Sandoz
Big pharma company Novartis announced on 25 August 2022 that it will spin off its generics and biosimilars arm, Sandoz.
New partnerships: Prestige-Intas and Samsung Bioepis-Samil
Prestige Biopharma (Prestige) and Intas Pharmaceuticals have entered a partnership to supply and commercialize Prestige Biopharma’s bevacizumab biosimilar in a number of countries globally. In addition, Samsung Bioepis has partnered with Samil to market their Lucentis (ranibizumab) biosimilar for ophthalmic diseases in South Korea.
Organon–Henlius partnership: biosimilars for women’s health
Organon, a global specialist in women’s health and expert in biosimilar commercialization, announced in mid-June 2022 that it had entered into an agreement with Shanghai Henlius Biotech, Inc. As part of this, Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab), and Prolia/Xgeva (denosumab) and will have global rights except for in China and its territories.
EMA authorizations: CRO generics suspended and Herceptin biosimilar refused
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has suspended the marketing authorizations of several generics medicines tested by Synchron Research Services on 20 May 2022. The committee also refused the marketing authorization for BioPharma’s Herceptin biosimilar, Tuznue, on 19 May 2022.
Lupin–Yabao partnership to bring paediatric medicines to China
In April 2022, global pharmaceutical company, Lupin announced that it has entered a strategic partnership with China’s Yabao Pharmaceutical Company. Together, the companies will work to meet the growing demand for quality drugs with paediatric formulations in Chinese markets.
Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing
In late-March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the start of its registrational clinical trials for BSC1020 and BSC0826 biosimilar filgrastim and on 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions in Puerto Rico.
Aurobindo acquires Veritaz and Formycon–ATHOS partnership
In April 2022, Indian drugmaker, Aurobindo Pharma, acquired formulations business Veritaz. In addition, biosimilars specialist, Formycon, signed a partnership deal with ATHOS to merge development activities surrounding two biosimilars.
Fresenius Kabi acquire mAbxience and Ivenix
Fresenius Kabi is acquiring a majority stake in biosimilars company mAbxience, and is acquiring infusion pump maker, Ivenix outright. The deals are set to be completed by mid-2022.
Cipla–mAbxience partnership in South Africa
Cipla Medpro announced a partnership agreement with the global biotechnology company mAbxience in March 2022. This aims to provide essential oncology and respiratory-related biosimilars in South Africa.
Biocon to acquire biosimilars business from Viatris
India-based biologicals specialist Biocon Biologics (Biocon) announced on 28 February 2022 that it has entered into a definitive agreement with its partner Viatris (formerly Mylan) to acquire the latter’s biosimilar business.
Private equity firms poised to bid for Sandoz takeover
Following the late 2021 reports that Novartis is considering a possible sale or spinoff of its generics (and biosimilars) unit, Sandoz [1, 2], two private equity firms are now reportedly discussing a joint bid for the unit.
AbbVie and Alvotech settle Humira (adalimumab) disputes
US firm AbbVie and Iceland-based Alvotech have announced a resolution to the patent and trade secret disputes regarding Humira (adalimumab), for which Alvotech is developing a biosimilar.
Biogen and Xbrane form agreement for arthritis biosimilar
Biogen and Xbrane Biopharma (Xbrane) have announced a commercialization and licensing agreement for a biosimilar of certolizumab pegol (Cimzia), which can be used to treat rheumatoid arthritis and other inflammatory conditions.
Axantia to market Lupin’s pegfilgrastim in the Middle East and North Africa
On 1 February 2022, Indian multinational pharmaceutical company Lupin Ltd announced that it was entering into a License, Supply and Technology Sharing agreement with Axantia, to market Lupin’s pegfilgrastim biosimilar in certain territories in the Middle East and North Africa.
Orion-CuraTeQ and Theramax-Enzene Biosciences partnerships
In January 2022, Finnish company Orion Corporation and CuraTeQ Biologics, subsidiary of India’s Aurobindo Pharma, announced their European expansion to the Baltic countries. This follows the December 2021 announcement that the UK’s Theramex entered into an agreement with India’s Enzene Biosciences to develop, register and commercialize a biosimilar of Roche’s RoActemra® (tocilizumab).
Biocon–Viatris merger expected
The merger of India’s Biocon Biologics and Viatris’ biosimilar business are reported to be in advanced stages.
Samsung to take full control of Samsung Bioepis
Korean electronics giant Samsung has made a deal with US biotechnology company Biogen Idec (Biogen) to take full ownership of their joint biosimilars venture, Korea-based Samsung Bioepis.
Top 10 most read GaBI Online articles in 2021
A review of the Top 10 most read articles reveals that biosimilars are still of most interest to readers. Some of the most memorable events for biosimilars in 2021 were recommendations for biosimilar approvals by the European Medicines Agency (EMA) and by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), as well as summaries of biosimilar approvals in Uruguay and Paraguay. Other subjects of interest included naming for biosimilars in the US, the interchangeability of EU biosimilars, Federal purchases of biologicals for cancer in Brazil. Finally, how patent litigation creates barriers to US biosimilar market growth and how competition from biosimilars drives price reductions for biologicals in France was also of interest to readers.
Fresh partnerships announced for ranibizumab and trastuzumab biosimilars
Prestige BioPharma has partnered with Dr Reddy’s Laboratories (Dr Reddy’s) to commercialize their trastuzumab biosimilar, HD201, while MS Pharma has joined up with Formycon for the commercialization of its ranibizumab biosimilar, FYB201.
Spinoff updates: Merck’s Organon and Novartis’ Sandoz
Merck spinoff Organon has announced third quarter revenue of US$1.6 billion in 2021. This shows slight decline in women’s health medications but growth in biosimilar sales. Following its 2021 third quarter review, Novartis is considering the spinoff of its biosimilar division, Sandoz, as a standalone company.
Swiss Social Democrat’s for nationalization of Sandoz
In November 2021, the Social Democratic party in Switzerland urged the government to buy Novartis AG’s generics and biosimilars unit, Sandoz.
Biocon Biologics and Serum Institute Life Sciences partnership
On 16 September 2021, a strategic partnership was announced between India-based biologicals specialist Biocon Biologics Limited (BBL), and Indian vaccine manufacturer Serum Institute Life Sciences (SILS), a subsidiary of Serum Institute of India Pvt Ltd.
Ustekinumab biosimilars: new international biopharma agreements
September and October 2021 saw new international agreements between biopharmaceutical companies regarding ustekinumab biosimilars. These were formed between BioFactura and Rani Therapeutics in the US, and China’s Bio-Thera Solutions and Pharmapark in Russia.
Agreement to produce similar biotherapeutic product in Turkey
On 22 October 2021, an important agreement was signed between Nobel Pharmaceuticals and the IBG-OzBio partnership for the manufacturing of a similar biotherapeutic product in Turkey. This hopes to be a springboard for further collaborations and medicinal product development in the country.
Collaborations to commercialize oncology biosimilars
New collaborations to commercialize oncology biosimilars have been announced between Sandoz and Bio-Thera Solutions, and between Innovent Biologics and Ascentage Pharma.
Licensing agreements signed for ustekinumab biosimilars
Bio-Thera Solutions have signed an exclusive commercialization and licensing agreement with Hikma Pharmaceuticals for the ustekinumab (Stelara) biosimilar BAT2206, similar to an agreement reached between Meiji Seika Pharma, Dong-A ST and Intas Pharmaceuticals.
Oncogen–BrightGene partnership
In June 2021, Malaysian oncology generics company, Oncogen, and China’s BrightGene Bio-Medical Technology announced that they are partnering to develop, manufacture, market and distribute generic drug products for the US market.
Menagen–CKD Middle Eastern partnership
Omani company, Menagen Pharmaceutical Industries and Korean company, Chong Kun Dang Pharmaceutical Corp (CKD), have formed a strategic partnership to provide biosimilars to countries in the Middle East.
Teva signs deal with Bioeq for ranibizumab biosimilar FYB201
Israeli generics giant Teva Pharmaceutical Industries (Teva) and Swiss biotechnology company Bioeq AG announced on 28 June 2021 that they had entered into a strategic partnership for the exclusive commercialization of Bioeq’s candidate ranibizumab biosimilar (FYB201) in Europe, Canada, Israel and New Zealand.
Organon launches as new global women’s health company and appoints leaders in Latin America
Organon celebrated its launch as a global women’s health company on 3 June 2021 with employees and women from around the world, as the Organon executive leadership team rings the opening bell at the New York Stock Exchange.
Prestige-Cytiva partnership and new Korean R & D facility
Singapore-based Prestige BioPharma, which specializes in the development of antibody therapeutics, is to build a new research and development (R & D) facility in the Republic of Korea and has entered a strategic partnership with Cytiva.
Theramex to market Prolia biosimilar in Europe and Australia
UK-based pharmaceutical company Theramex UK Ltd, which focuses on women’s health, has announced an agreement with India’s Enzene Biosciences Limited for the registration and commercialisation of a Prolia (denosumab) biosimilar in Europe and Australia.
AbbVie antitrust investigation and Sandoz biosimilar delay
In May 2021, following the release of a report, it was announced that AbbVie is likely to be subject to an antitrust investigation due to claims it has delayed market entry of biosimilars of Humira (adalimumab). Alvotech also raised a complaint against AbbVie after being sued over their Humira biosimilar application. In addition, the US Supreme Court denied Sandoz the ability to release its Enbrel (etanercept) biosimilar.
Merck partners with Indian drugmakers to increase access to COVID-19 drug
On 27 April 2021, Merck & Co Inc (also known as MSD Pharmaceuticals) announced that it had partnered with five Indian generic drug manufacturers to expand production and access to its experimental COVID-19 drug.
Bevacizumab and insulin aspart non-originator biologicals to be sold in Russia
Singapore-based Prestige Biopharma (Prestige) has formed an agreement with Russian company Pharmapark to commercialize Prestige’s bevacizumab non-originator biological in Russia. Russian company Geropharm has also launched an insulin aspart non-originator biological on the market in the country.
Huons Lab and PanGen Biotech to develop denosumab biosimilar
On 20 April 2021, Korean pharmaceutical company, Huons Lab, announced the development of a denosumab biosimilar to treat osteoporosis. The company is working with PanGen Biotech and using their cell line culturing and purification technology.
PlantForm and partners in Brazil to develop pembrolizumab biosimilar
Canada-based PlantForm Corporation (PlantForm) have signed an agreement with partners in Brazil to develop a biosimilar of the cancer treatment pembrolizumab (Keytruda).
Biocon partners with Libbs for the sale of generics in Brazil
India-based biologicals specialist Biocon has formed an out-licensing agreement with Brazil-based company Libbs Farmaceutica for the sale of generic drugs in the country, marking Biocon’s entry into the Latin American market for generics.
New partnerships for Cipla and Samsung Bioepis
In March 2021, Cipla announced that its subsidiary, Cipla Gulf is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. Samsung Bioepis also announced that it has signed a marketing partnership with Yuhan to launch its biosimilar of Humira (adalimumab), Adalloce, in South Korea.
Pfizer sells Chinese copy biologicals plant to WuXi Biologics
China-based WuXi Biologics announced on 17 March 2021 that it had made an agreement with Pfizer China to acquire its state-of-the-art biologicals manufacturing facilities as well as its labour force in Hangzhou, China.
Sandoz acquires GSK antibiotics and Perrigo generics sold to Altaris
In February 2021, Sandoz signed an agreement to acquire GSK’s cephalosporin antibiotics business. In March 2021, Perrigo Company sold their generic drug business to private investment firm, Altaris Capital Partners LLC.
Biocon Biologics partners to improve global access to cancer treatments and insulin
In February 2021, Biocon Biologics joined forces with international organizations to improve access to cancer and diabetes treatments. The India-based biological subsidiary of Biocon, entered into an agreement with the Clinton Health Access Initiative (CHAI) to expand access to cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP) [1]. In addition, they have become the first biosimilar insulin company to partner with the International Diabetes Federation (IDF) to promote and support the latter’s initiatives [2].
Korean biosimilars makers pipelines and expansion
Korean biosimilars makers have started conducting global clinical trials and are expanding into other markets with their biosimilars.
Innovent makes deal for bevacizumab copy biological in Indonesia
China-based Innovent Biologics (Innovent) announced on 19 January 2021 that it had made an agreement with PT Etana Biotechnologies Indonesia (Etana) to out-license the development and commercialization rights for its bevacizumab copy biological, Byvasda, in Indonesia to Etana.
Partnerships formed and extended between Isu Abxis/Pharmasyntez and Alvotech/Fuji Pharma
The South Korean company Isu Abxis will export technology for a rare blood disease treatment, a biosimilar of Soliris, to the Russian firm Pharmasyntez.
Top 10 most read GaBI Online articles in 2020
This article reviews some of the most important events for biosimilars during 2020. For biosimilars these included the World Health Organization’s (WHO) prequalification of its first biosimilar and US Food and Drug Administration (FDA) rules and guidance. Other subjects of interest for biosimilars were European Medicines Agency (EMA) approvals, the biosimilars market in Latin America, biosimilar litigation, and extrapolation, immunogenicity, switching and substitution of biosimilars.
Celltrion: Takeda acquisitions and new plant development
Celltrion completed the acquisition of selected primary care assets from Takeda Pharmaceutical Company Limited in the Asia Pacific region in November 2020. In addition, the company announced it will be building a new biopharmaceutical plant and a global biotechnology research centre in Songdo, Incheon, South Korea.
Momenta to reduce its biosimilars programmes
US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 October 2018 that it would be focusing on two key biosimilars and quit the development of five others.
New Alvotech partnerships in South Africa and China
Iceland-based biopharmaceutical company Alvotech entered into two partnerships in November 2020, that will expand their reach into South Africa and China.
AffaMed and EverInsight merger announced
AffaMed Therapeutics announced a merger agreement with EverInsight Therapeutics on 10 October 2020.
Essex and Henlius collaborate to deliver bevacizumab biosimilar for ophthalmic diseases
On 15 October 2020, it was announced that two Essex Bio-Technology subsidiaries were entering an agreement with Shanghai Henlius Biotech. Under this, Essex Bio-Investment and Zhuhai Essex Bio-Pharmaceuticals will work with Henlius to co-develop a bevacizumab biosimilar for the treatment of ophthalmic diseases.
Medicure and Reliance sign cardiovascular drug agreement
Medicure Inc announced on 5 October 2020 that it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences Private Limited (RLS) for a cardiovascular drug. Under this agreement, Medicure is responsible for the regulatory approval process for the drug product and is granted the exclusive right to market and sell it in Canada, European Union and the US. The cardiovascular drug is currently unnamed.
Aurobindo and Huons refocus their biologicals/biosimilars portfolios
India-based generics maker Aurobindo Pharma (Aurobindo) has announced a renewed product focus and plans for the biosimilars of its subsidiary company. In addition, Korea-based Huons will collaborate with Singapore-based Prestige BioPharma’s (Prestige) to enter the biosimilars market.
Lotus to distribute CKD’s biosimilar darbepoetin alfa in South East Asia
On 18 September 2020, Taiwan-based Lotus Pharmaceutical Co (Lotus) announced a long-term collaboration with Korea-based Chong Kun Dang Pharmaceutical Corp (CKD) for the distribution of biosimilar darbepoetin alfa (CKD-1110) in South East Asia.
Henlius and Accord collaborations will see their trastuzumab biosimilar launch globally
On 30 September 2020, Accord Healthcare (Accord) and Shanghai Henlius Biotech announced that they are to enter a new collaboration. As part of their agreement, Henlius will grant an exclusive licence to Accord US to develop and commercialize their trastuzumab biosimilar in Canada and the US. This follows the June 2018 Henlius‒Accord UK licence agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 trastuzumab. This led the product being approved by the European Commission in July 2020 [1] and its UK launch on 24 September 2020.
Mylan-Upjohn merger receives go ahead from Europe, Australia and New Zealand
The proposed merger between Mylan and Pfizer’s Upjohn receives the go-ahead from authorities in Europe, Australia and New Zealand. The agreement to combine the two companies was finalised on 29 July 2020. However, the transaction was held-up due to the COVID-19 pandemic and is now likely to close in the later part of 2020.
Bio-Thera and BeiGene sign deal to license, distribute and supply Avastin copy biological BAT1706 in China
On 24 August 2020, China-based pharmaceutical companies Bio-Thera Solutions (Bio-Thera) and BeiGene announced that they have entered into a license, distribution and supply agreement for BAT1706, an investigational copy biological to Avastin® (bevacizumab), in China.
Ligand to acquire biosimilars manufacturer Pfenex
Ligand Pharmaceuticals Incorporated (Ligand) is to acquire Pfenex Inc (Pfenex), a manufacturer of biosimilars including teriparatide, ranibizumab and pegfilgrastim.
Kodak Pharmaceutical deal under scrutiny
In late July 2020, US President Donald Trump announced that the Federal Government would be loaning Eastman Kodak Co US$765 million to develop generic drugs. This is the first loan to be granted under the US Defense Production Act that was passed in response to the global COVID-19 pandemic. Now, amid allegations of insider trading, the House of Representatives will review the Kodak Pharmaceutical deal and there will be a Securities and Exchange Commission (SEC) investigation.
Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries
China-based biopharmaceutical company Bio-Thera Solutions (Bio-Thera) announced on 18 July 2020 that it has signed a licensing agreement for its proposed golimumab biosimilar BAT2506 with Russia-based Pharmapark.
Teva changes course in Japan and the US
Israeli drugs manufacturer Teva has made strategic decisions in the US and Japan. The company plans to strip back its Japanese venture with Takeda, selling off parts of the portfolio by early 2021. However, in the US, Teva will be entering a strategic partnership with Alvotech for the commercialization of five biosimilar candidates.
Perrigo sells its UK generic drug business
Perrigo Co Plc (Perrigo) has sold its generic prescription drug business to a private equity firm in a deal worth US$195 million.
COVID-19 drug trials underway
There are over 200 trials for COVID-19 currently in progress. These include trials of monoclonal antibodies, including from the South Korean firm Celltrion, as well as vaccines, notably from the Chinese firm CanSino Biologics.
Aurobindo/Sandoz deal falls through, biosimilars business transferred to subsidiary
It has been announced that Aurobindo Pharma’s planned deal to take over the US generic oral solids and dermatology businesses of Sandoz has fallen through. More recently, the company has transferred its biosimilars business to its wholly owned subsidiary CuraTeQ Biologics.
Fresenius Kabi signs marketing agreement for adalimumab biosimilar
German pharmaceutical company Fresenius Kabi has signed an agreement with methotrexate supplier Medac for the sale of its adalimumab biosimilar Idacio. The agreement is likely to boost sales of Idacio.
Success for Celltrion in Japan and Samsung Bioepis in Europe
South Korean biosimilar manufacturer Celltrion’s trastuzumab biosimilar has gained a 40% market share in Japan. Meanwhile, Samsung Bioepis, which is also headquartered in South Korea, announced European sales in excess of US$200 million in the first quarter of 2020.
Canadian firm Bausch + Lomb signs agreement on Lucentis biosimilar
Canadian eye health specialists Bausch + Lomb have signed an exclusive licensing agreement with Stada and its development partner Xbrane to develop and commercialize a Lucentis biosimilar in Canada and the US.
Mycenax sells tocilizumab biosimilar to Richter
Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.
Dr Reddy’s buys Wockhardt plant and Strides acquires 18 ANDAs
Dr Reddy’s Laboratories (Dr Reddy’s) is to acquire US$260 million worth of Wockhardt’s business including a major manufacturing facility in India, while Strides is to acquire 18 abbreviated new drug applications (ANDAs) for the US market.
FDA’s response to coronavirus
In response to the coronavirus pandemic, the US Food and Drug Administration (FDA) has issued a comprehensive statement regarding effects on the supply chain and inspections of plants overseas.
Roche continues litigation in India and receives fine in Romania
Switzerland-based pharmaceutical giant Roche is continuing to pursue legal action in India over a trastuzumab similar biologic and has recently been fined in Romania for delaying the entry of biosimilars to the market.
New biosimilars partnerships from Alvotech and Biocon
Alvotech has formed an exclusive partnership with JAMP Pharma (JAMP) for the commercialization of its biosimilars in Canada, while Biocon has expanded its collaboration with Equillium to include Australia and New Zealand.
Amgen to buy out Japanese partner Astellas
US-based biotech giant Amgen has announced that it will dissolve its joint venture with the Japanese company Astellas in order to operate the unit independently. This means Astellas will become a wholly-owned Amgen affiliate.
Celltrion to build facility in China and increase new drug output
South Korean biotechnology company Celltrion has announced plans to build its first overseas factory in China. The company also intends to release one new biosimilar per year until 2030.
Merck to create spin off for women’s health and biosimilars
US pharma giant Merck is to create a spin-off company for its women’s health, biosimilars and legacy products, allowing the main company to focus on blockbuster cancer drug Keytruda (pembrolizumab).
US health insurers partner with generics maker Civica
The Blue Cross Blue Shield Association (BCBSA), a federation of health insurers in the US, has formed a partnership with generics manufacturer Civica Rx to reduce the costs of generic drugs.
Coherus signs licensing deal for bevacizumab biosimilar in the US
US-based Coherus BioSciences (Coherus) announced on 13 January 2020 that it had entered into a licensing agreement with Chinese biopharmaceutical firm Innovent Biologics (Innovent) for its bevacizumab product, IBI305.
Top 10 most read GaBI Online articles in 2019
It has once again been a busy year for biosimilars. One of the most important milestones for biosimilars in 2019 was the World Health Organization (WHO) pilot programme to prequalify rituximab and trastuzumab biosimilars. Other subjects of interest for biosimilars were US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, naming and regulation of biosimilars, as well as biosimilar guidance, uptake and switching.
Mundipharma and Samsung Bioepis partner for biosimilars in Hong Kong and Taiwan
Mundipharma announced on 13 January 2020 that it had entered into a partnership with Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) to commercialize four biosimilar candidates from Samsung Bioepis in Hong Kong and Taiwan.
Japanese firms to collaborate on Eylea biosimilar
Japanese pharmaceutical firms Gene Techno Science and Kishi Kasei announced on 2 December 2019 an agreement for the joint development of an aflibercept biosimilar, a treatment for macular degeneration to rival the reference drug Eylea.
Samsung Bioepis expands biosimilars agreement with Biogen
Korean biosimilars giant Samsung Bioepis has extended its commercialization agreement with Biogen to include biosimilars to two ophthalmology drugs, Lucentis (ranibizumab) and Eylea (aflibercept). The agreement also allows Biogen to commercialize Samsung’s blockbuster anti-inflammatories in Europe for an additional five years.
Alvotech signs agreements with Stada and Yas Holding
Alvotech has entered into a strategic biosimilars collaboration with German company Stada. The company has also announced a significant investment from Abu Dhabi-based company Yas Holding for the exclusive supply of biosimilars in the Middle East and North Africa.
Lupin to sell its Japanese arm and Sandoz to acquire Aspen’s Japanese business
On 11 November 2019, India-based Lupin announced that it has agreed to sell its entire stake in its Japanese subsidiary Kyowa Pharmaceutical Industry Co to Japan-based private equity firm Unison Capital for an enterprise value of Yen 57.36 billion.
Alvogen gains exclusive rights to market parathyroid biosimilar in three countries
American pharmaceuticals firm Alvogen has announced exclusive commercialization agreements to distribute and market a teriparatide biosimilar in Canada, Israel and South Korea.
Biocon acquires Pfizer research facility and signs licensing agreement with Evotec
India-based biologicals specialist Biocon has announced the acquisition of a research and development facility from Pfizer Healthcare India Ltd and signed a strategic licensing agreement for an early-stage biosimilar with Evotec Biologics.
Lupin to sell Japanese injectables business and collaborates with German drugmaker on anticancer treatment
India-based generics manufacturer Lupin Ltd – the eighth biggest generics company in the world – has announced the sale of its Japanese injectables business to a subsidiary of the United Arab Emirates’ (UAE) largest pharmaceutical manufacturer.
Further collaborations formed to penetrate China’s generics market
The Chinese pharmaceutical market is the second largest in the world, and generic drugs make up 70% of its value. Continued growth of China’s generics industry is anticipated owing to rapid population ageing and government policies to promote generics [1]. It is therefore not surprising that generic drug manufacturers are keen to penetrate this market, and indeed over the last few months there have been a number of collaborations with this objective [2-4]. Most recently, Japanese drugmakers Eisai and Nichi-Iko Pharmaceutical entered into a collaboration agreement to sell generic drugs in China, while Sun Pharmaceutical Industries (Sun Pharma) partnered with China Medical System Holdings (CMS) to develop and commercialise generics in China.
Celltrion contracts Lonza to manufacture autoimmune treatment Remsima
South Korean biosimilars manufacturer Celltrion have announced a deal with Swiss contract manufacturing organisation (CMO) Lonza to produce its autoimmune biosimilar Remsima at a facility in Singapore.
Shanghai Pharma and Russia’s Biocad form joint venture to sell cancer and autoimmune drugs in China
Shanghai Pharmaceuticals Holding and Russia’s Biocad Pharmaceutical have agreed to form a joint venture to develop, manufacture and market cancer and autoimmune disease treatments in China.
Sandoz makes deal with Polpharma for natalizumab biosimilar
Sandoz, the generics division of Novartis, and Poland-based Polpharma Biologics announced on 3 September 2019 that they had signed a worldwide agreement giving Sandoz commercialization rights to Polpharma’s candidate natalizumab biosimilar (PB006).
Huons enters biosimilar market while private equity firm PAG invests in Hisun BioRay
Huons has announced its plans to enter the biosimilar market, and private equity firm PAG has acquired a controlling interesting in Hisun Pharmaceutical’s biopharmaceutical subsidiary, Hisun BioRay.
Alvotech and Cipla Gulf partnership announced
On 29 July 2019, pharmaceutical companies Alvotech and Cipla Gulf announced that they have entered into an exclusive partnership for the commercialization of an adalimumab biosimilar (AVT02), in a selection of emerging markets.
Agreement between Hikma and Civica to reduce US generic drug shortages
Hikma Pharmaceuticals Plc and Civica Rx announced a five-year agreement on 23 July 2019. Under the agreement, Hikma will manufacture and supply 14 essential sterile injectable medications for Civica. It will use Hikma's abbreviated new drug applications (ANDAs) and Civica's labelling and National Drug Code (NDC). The full list of medications included in the agreement, that are often in short supply in US hospitals, will be publicly announced in the near future. Initial shipments are expected by the end of 2019.
WHO essential medicines list: new lung cancer medicines rejected
The World Health Organization’s (WHO) list of ‘essential medicines’, received a biennial update on 9 July 2019. It added 28 drugs but left out several new treatments for lung cancer.
Prestige and Pharmapark make deal for trastuzumab biosimilar
Singapore-based Prestige BioPharma (Prestige) and Russia-based Pharmapark announced on 8 July 2019 that they had signed an exclusive partnership and supply agreement for Prestige’s candidate trastuzumab biosimilar (HD201) in Russia.
Celltrion and Nan Fung Group form joint venture for copy biologicals in China
South Korean biosimilars firm Celltrion and Hong Kong-based Nan Fung Group announced on 18 July 2019 that the two companies had formed a joint venture, Vcell Healthcare, with the aim of developing and commercializing copy biologicals in China.
STADA and Xbrane strengthen biosimilars collaboration
German generics giant Stada Arzneimittel (Stada) and Swedish biotech company Xbrane Bioscience (Xbrane) announced on 31 May 2019 that they have expanded their strategic biosimilar development partnership.
Boehringer Ingelheim finally signs licensing deal for Humira biosimilar
Boehringer Ingelheim (Boehringer) has finally given in and signed a licensing deal for its Humira biosimilar, Cyltezo (adalimumab), in the US.
Sandoz and EirGenix make deal for trastuzumab biosimilar
Sandoz, the generics division of Novartis, announced on 30 April 2019 that it had signed an agreement with Taiwan’s EirGenix to market a proposed trastuzumab biosimilar.
Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan
Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar, Stelara, in Japan.
Alteogen gains patent on SC trastuzumab biosimilar
South Korean biologicals company Alteogen announced on 27 March 2019 that it had gained a patent for a subcutaneous version (ALT LS2) of its candidate trastuzumab biosimilar (ALT L2).
First Chinese biologicals maker receives EMA GMP certification
China-based WuXi Biologics announced on 20 March 2019 that it had received good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).
Belgian companies make biosimilars agreement
Belgian companies SYnAbs and Univercells announced on 20 April 2019 the signing of a service agreement for an undisclosed monoclonal antibody biosimilar.
Celltrion has renewed success with leukaemia biosimilar Truxima and expands markets in Europe and Latin America
In recent months, South Korean biosimilars firm Celltrion has announced a series of successes, including winning a patent case against Samsung Biogen and expansions in the European and Latin American markets.
Novo Nordisk granted exclusivity on GLP-1 agonist Victoza until 2023
Novo Nordisk has announced a settlement with Teva Pharmaceuticals (Teva) giving the company at least four years before it has to compete with biosimilar versions of its diabetes injectable Victoza (liraglutide).
AbbVie and Coherus sign licensing deal for Humira biosimilar
Coherus BioSciences (Coherus) announced in January 2019 that it had entered into global settlement agreements with AbbVie which resolve all pending disputes related to CHS-1420, Coherus’s proposed biosimilar of AbbVie’s Humira (adalimumab).
Under the terms of the settlement, Coherus will have global non-exclusive licence rights to commercialize CHS-1420 and will pay royalties to AbbVie. The licence period for CHS-1420 in the US will begin on 15 December 2023.
Fujifilm acquires Biogen Hillerød facility for US$890 million
On 12 March 2019, Biogen announced that it had entered into an agreement with Fujifilm Corporation under which Fujifilm will acquire Biogen Manufacturing ApS from Biogen for up to US$890 million in cash. Biogen Manufacturing ApS is a large-scale biologicals manufacturing site located in Hillerød, Denmark (Biogen Hillerød). Biogen Hillerød will become Fujifilm's fourth biopharmaceutical contract development and manufacturing site upon closure of this transaction, which is expected in August 2019 subject to closing conditions. The existing workforce at the site, consisting of approximately 800 employees, will continue employment under Fujifilm.
Boehringer wins access to Humira documents as Janssen’s Remicade is relisted in Quebec
Boehringer Ingelheim is the only biosimilar manufacturer still challenging AbbVie’s Humira (adalimumab) patents in court, and has just won a legal battle to gain access to documents AbbVie has fought hard to keep private. Meanwhile, Janssen has had Remicade (infliximab) reinstated on Quebec’s List of Medications after a decision by the Minister of Health and Social Services to “delist” Remicade was declared invalid and overturned.
Sandoz makes biological deal in China
Sandoz has made a deal for copy biological in China in December 2018, and received approval of an extra indication for its biosimilar etanercept in January 2019.
AbbVie makes more deals delaying adalimumab biosimilars in the US
Last update: 14 December 2018
US-based pharma giant AbbVie has signed yet more deals with biosimilars makers regarding biosimilar versions of its blockbuster arthritis drug Humira (adalimumab).
Samsung Bioepis makes deals for copy biologicals in China
Samsung Bioepis has made deals with two Chinese firms to expand its business in the country.
Fuji Pharma acquires stake in Alvotech
Iceland-based biopharmaceutical company Alvotech announced on 19 November 2018 that Japan-based Fuji Pharma was investing in the company.
Glenmark makes deal for ophthalmic generics
Indian generics maker Glenmark Pharmaceuticals (Glenmark) has entered into an exclusive agreement with South Korea’s Sam Chun Dang Pharm (SCD) to develop, manufacture and market a portfolio of generic ophthalmic products in the US and Canada.
Top 10 most read GaBI Online articles in 2018
A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were the rejections by the US Food and Drug Administration (FDA) of four biosimilars and the agency’s update on its naming guideline for biologicals. Other subjects of interest for biosimilars were European Medicines Agency approvals, the US biosimilars market, biosimilar policies in Europe, position statements on biosimilars and interchangeability and switching.
Samsung BioLogics sues Korea’s FSC over accounting discrepancies
Samsung BioLogics is fighting back against allegations of accounting fraud and has launched a lawsuit against the South Korean financial authority, the Financial Services Commission (FSC).
Health care in Iraq saves money by incorporating off-patent biologicals
Iraq is one of many countries determined to increase its budget savings by replacing appropriate originator biologicals with off-patent biologicals. This is due to the recognition of the proven impact off-patent biologicals have on the financial burden of healthcare systems worldwide [1, 2].
