Biosimilars

FDA approves etanercept biosimilar Eticovo

Korean biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 25 April 2019 that it had received approval from the US Food and Drug Administration (FDA) for its etanercept biosimilar.

ASCO/ASH update ESA recommendations

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have updated their recommendations on the management of cancer-associated anaemia with erythropoiesis-stimulating agents (ESAs).

Biosimilar comparability assessment

In a recent review, Ishii-Watabe and Kuwabara summarize the principles of biosimilar development and outline key considerations for studies comparing a biosimilar with its reference product [1].

FDA to hold public meeting on access to affordable insulin

The US Food and Drug Administration (FDA) is seeking input on the challenges and opportunities the agency should consider as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products, as well as about the development process for such products.

Comparability of biosimilar Ontruzant maintained over three years

Samsung Bioepis has presented positive long-term results for its trastuzumab biosimilar Ontruzant (SB3) at the 16th International Maternal Cancer Congress St Gallen 2019, which was held in Vienna, Austria.

Intas launches trastuzumab similar biologic in India at 65% discount

India-based generics maker Intas Pharmaceuticals (Intas) announced on 9 April 2019 the launch of its product Eleftha, a ‘similar biologic’ of trastuzumab, in India. The new product, claims the company, will bring down the cost of breast cancer treatment by nearly 65%.

Clinical development of a bevacizumab biosimilar

Authors, Kambiz Novin and Nafiseh Mortazavi, from medical faculties of Iranian Universities, discuss the methodological considerations for the clinical development of a bevacizumab biosimilar [1].

Biosimilar drug packaging does not meet EU guidelines on readability

Analysis of 35 biosimilar medicines licensed by the European Medicines Agency (EMA) finds packaging to be more complex than recommended. None of the packaging leaflets analysed were found to be ‘easy to understand’, with sections on therapeutic indication and side effects found to be the most complex [1].

Rituximab biosimilar Truxima approved in Canada

Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, announced on 10 April 2019 that Health Canada had approved its rituximab biosimilar Truxima. This marks the first rituximab biosimilar to be approved by the Canadian medicines’ regulator.

Eli Lilly to introduce half-price authorized insulin biosimilar in US

With high drug prices increasingly coming into the spotlight, Eli Lilly has announced that it will introduce a lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

Economic considerations for biosimilars in the US

Smeeding and colleagues explore cost considerations related to biosimilars in the US, and present a broad perspective on value beyond price reduction in a recent review. 

EC approval for adalimumab biosimilar Idacio

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar Idacio (MSB11455).

Efficacy and safety of bevacizumab biosimilar ABP 215

Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

Key considerations for biosimilars in the US

Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake. 

Biocad advancing its non-originator biologicals in Russia

Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.

ESMO survey highlights need for education and alignment

The results of a survey carried out by the European Society for Medical Oncology (ESMO) on biosimilars understanding in oncologists have highlighted the need for education and worldwide alignment [1].

Sandoz resubmits pegfilgrastim biosimilar to FDA

Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).

Phase III clinical trials started for adalimumab biosimilars

Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.

Samsung Bioepis invalidates Herceptin patent in Korea

Samsung Bioepis has won a patent invalidation suit against Roche’s Herceptin in Korea.

Biosimilars of pertuzumab

Pertuzumab is a monoclonal antibody 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.

How can EU policymakers access the potential of biosimilars

Policymakers in Europe should introduce a long-term, multi-stakeholder framework to realize the full potential of off-patent biologicals and biosimilar drugs, according to the results of a series of roundtable discussions held with clinicians, government bodies and industry representatives [1].

Japanese approval for Lupin’s etanercept biosimilar

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.

Comparison of autoinjectors for inflammatory joint or bowel disease

Imraldi is a biosimilar of the antitumour necrosis factor (TNF) monoclonal antibody adalimumab. It was approved in Europe in August 2017 for the treatment of various inflammatory conditions [1].

Biosimilars of somatropin

Somatropin or human growth hormone (hGH) is a peptide hormone that stimulates growth, cell reproduction and cell regeneration in humans and other animals. It is thus important in human development. It is a type of mitogen which is specific only to certain kinds of cells. Growth hormone is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland.

Bio-Thera advances bevacizumab and tocilizumab copy biologicals

China-based Bio‑Thera Solutions (Bio‑Thera) has made a licensing agreement for its bevacizumab copy biological and has started a phase III trial for its tocilizumab copy biological.

FDA approves trastuzumab biosimilar Trazimera

Pharma giant Pfizer announced on 11 March 2019 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Roche’s Herceptin (trastuzumab).

Clinician biosimilar prescribing habits and need for education

At present, biosimilar prescribing and clinical use remain contingent on individual healthcare provider preferences. Although novel legislation and policy continue to promote biosimilar drug development, clinician hesitancies curtail biosimilar use in practice, thereby limiting overall market uptake. Findings from a recently published systematic review indicate that clinicians in Europe and the US do not primarily support the use of biosimilars as safe and effective therapies in patients already receiving originator biological treatment [1].

Celltrion wins biosimilar deals and Duopharma increases focus on biosimilars in SE Asia

Celltrion Healthcare (Celltrion) has won tenders to supply infliximab to Singapore and rituximab to Thailand, while CCM Duopharma Biotech Bhd (CCMD) aims to increase revenue contribution from its biosimilar products from 22% to over 25%.

Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO

Authors Marcos Renato de Assis and Valdair Pinto outline the strengths and weaknesses of the Brazilian regulation on follow-on biologicals and compare  regulations in Europe, the US and the world [1].

China approves rituximab copy biological

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.

UK’s NICE recommends pertuzumab with biosimilar trastuzumab

The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous biosimilar trastuzumab and chemotherapy for the treatment of breast cancer.

Copy biologicals approved in China

Last update: 2 April 2021

In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).

Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin

Results of a study of Pfizer’s trastuzumab biosimilar (PF 05280014) have shown that the biosimilar is non-inferior to the originator biological, Roche’s Herceptin (trastuzumab) [1].

Impact of proposed changes to FDA approach to biosimilars

In the Opinion article, Professor Sarfarez Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development [1]. Niazi’s proposals are consistent with the anti-regulatory political rhetoric and administrative actions that are becoming increasingly widespread in the US. In this article, Professor Pekka Kurki comments on some of Niazi’s proposals from a global perspective [2].

EC approval for bevacizumab biosimilar Zirabev

US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval for its bevacizumab biosimilar Zirabev (PF 06439535).

Positive phase I results for Mycenax’s tocilizumab biosimilar

Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab biosimilar, LusiNEX, had met its primary endpoints.

Green Shield Canada’s biosimilar switch pilot a success

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in December 2018 that its biosimilar transition pilot had been successfully completed.

Mandatory and non-mandatory switching for biosimilars

Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

Monoclonal antibody copy biologicals accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (IB 305 and HLX22).

Positive phase III results for rituximab biosimilar ABP 798

Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab).

Pfizer drops five preclinical biosimilar programmes

US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.

Questions over DANBIO relevance for non-medical switching

Italian rheumatologists Fabrizio Cantini and Maurizio Benucci commented on the paper from Glintborg and co-authors ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

EC approval for pegfilgrastim biosimilar Fulphila

In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.

Biosimilar teriparatide approved for the treatment of osteoporosis

Osteoporosis is a modern day epidemic longevity has brought about and represents an enormous socioeconomic burden. Being largely asymptomatic the silent thief can get away with insidiously stealing the patient’s bones until, as a result of the relentless bone loss, fragility fractures inevitably occur. The first, so-called sentinel fracture is the forerunner of the devastating fracture cascade as any prior fracture translates into a two- to four-fold increase in the risk of sustaining a subsequent one within one year [1].

Three FDA approvals for Glenmark as it enters US branded dermatology market

Glenmark Pharmaceuticals Inc has been granted approval by the US Food and Drug Administration (FDA) for its generic versions of Zytiga, DermOtic oil and Qudexy XR, and has announced its entry into the US branded dermatology segment.

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the authorized indications without an unacceptable incidence of adverse effects. This monitoring can be carried out using pharmacovigilance (PhV) procedures, which are vital in the identification and prevention of adverse drug reactions (ADRs). Due to the inherent variability of bioproduction, this is of paramount importance for biological products, including biosimilars.

PanGen gains Malaysian approval for epoetin alfa biosimilar

South Korea-based biotechnology company PanGen Biotech (PanGen) announced on 7 February 2019 that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoetin alfa biosimilar.

European regulatory framework for approval of biosimilars – perspectives and future developments

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions. In Europe, the European Medicines Agency (EMA) has already more than 10 years of experience with review of applications and approval of biosimilars for use in the European Union.

Long-term stability of trastuzumab biosimilar under various storage conditions

Trastuzumab (TTZ) is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2). In some cancers, including certain types of breast cancers and gastric cancers, HER2 is overexpressed, causing cancer cells to reproduce uncontrollably. TTZ can be used in the management of these cancers.

EMA approval for adalimumab biosimilars Idacio and Kromeya

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2019 that it had recommended granting marketing authorization for the adalimumab biosimilars Idacio and Kromeya.

Barriers and facilitators to biosimilar prescribing in the UK

At present, the rate of uptake of biosimilars is keenly debated among stakeholders in different healthcare specialties. Aladul et al. examined the perspectives on biosimilars among healthcare professionals (HCPs) from gastroenterology, rheumatology and diabetes specialities to shed light on barriers and facilitators to their prescribing in the UK [1]. In a qualitative, cross-sectional study, 22 HCPs (consultants, nurses and pharmacists) from five hospitals in the West Midlands were interviewed.

Australia’s PBAC recommends substitution of adalimumab biosimilars

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Humira on the Australian Pharmaceutical Benefits Scheme (PBS).

Tanvex BioPharma submits filgrastim biosimilar to Health Canada

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada for its proposed filgrastim biosimilar TX01.

Liability chain of biosimilar switching

When an adverse event to a medicinal product, or a loss of efficacy, is experienced by a patient, the liability chain may potentially involve both the manufacturer and/or Marketing Authorization Holder (MAH) (products liability) and the healthcare professionals responsible for prescribing, dispensing and/or administrating (professional liability) the medicine.

FDA approves trastuzumab biosimilar Herzuma

On 14 December 2018, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.

Adalimumab biosimilar Imraldi makes waves in Europe

Korean biosimilars maker Samsung Bioepis has gained more than 60% of the adalimumab market in Germany for its adalimumab biosimilar, Imraldi. But it’s not just Imraldi and not just in Germany, the company’s accumulated sales for three of its biosimilars in Europe reached US$545.2 million in 2018.

Biosimilars - to switch or not to switch

Authors Marc Scherlinger and Thierry Schaeverbeke commented on the paper from Glintborg and co-authors ‘To switch or not to switch’ ,which reported the results of biosimilar etanercept switching in Denmark [1].

FDA approves trastuzumab biosimilar Ontruzant

On 18 January 2019, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Ontruzant (trastuzumab-dttb), for the treatment of patients with breast and gastric cancer.

Biosimilars applications under review by EMA – January 2019

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Alteogen wins process patent for aflibercept biosimilar

South Korean biologicals company Alteogen announced on 4 January 2019 that it had been granted a process patent for its method of producing an aflibercept biosimilar, ALT‑L9, referencing Regeneron’s blockbuster drug Eylea (aflibercept). The patent is a novel method for producing the anti-vascular endothelial growth factor (anti-VEGF) fusion protein.

Positive phase III results for rituximab biosimilar CT-P10

Celltrion has presented positive phase III results for its rituximab biosimilar CT‑P10 at the American Society of Hematology Meeting (ASH) annual meeting.

CKD Pharma’s darbepoetin alfa biosimilar launched in Japan

On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).

EMA continues to be open to alternative clinical development strategies for biosimilars

In the European Union (EU) and other highly regulated markets, companies need to prove the similarity of proposed biosimilars to the established reference product for gaining market authorization. European regulators recommend using a stepwise approach whose first steps consist of a demonstration of similarity at the analytical level and via non-clinical studies. In addition, as a later step, clinical studies are an important source of additional evidence.

Positive phase III results for rituximab biosimilar PF 05280586

Pfizer has presented positive phase III results for its rituximab biosimilar PF‑05280586 at the American Society of Hematology Meeting (ASH) annual meeting.

Celltrion wins patent suit in Japan over trastuzumab biosimilar

South Korean biotechnology company Celltrion announced on 5 November 2018 that it had won a patent suit in Japan involving its trastuzumab biosimilar, Herzuma (CT‑P6)

EMA approval for bevacizumab biosimilar Zirabev

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.

Long-term follow-up of switching to biosimilar infliximab

A study of long-term follow-up data after switching to biosimilar infliximab appears to show identical retention rates, according to French researchers [1].

Trastuzumab and agalsidase beta biosimilars launched in Japan

Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.

Biosimilars makers in Canada to launch patient support programme

Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen pharmaceutical service provider Innomar Strategies to be the preferred provider for the association’s Patient Support Program (PSP) platform.

WHO should finalize its BQ guidance

According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer of biologicals, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including those in the Middle East and North Africa (MENA) region, have access to high quality, affordable medicines [1].

British diabetologists issues position statement on biosimilar insulin

The Association of British Clinical Diabetologists (ABCD) has issued a position statement on the use of biosimilar insulin. The statement summarises information on the advantages and disadvantages of using biosimilar insulins and gives the association’s position on when biosimilar insulins be used [1].

Biosimilars launched in the US at a significant discount

Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.

Positive results for adalimumab and etanercept biosimilars from Sandoz

On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etanercept biosimilars [1, 2].

FDA approves first rituximab biosimilar Truxima

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).

Boehringer Ingelheim and Sandoz abandon biosimilars

Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.

Positive results for Chinese rituximab and trastuzumab copy biologicals

Researchers from Shanghai Henlius Biotech have presented positive phase III study results for their rituximab [1] and trastuzumab [2] copy biologicals.

Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 9 October 2018 that results from two phase I studies of its pegfilgrastim biosimilar (MSB11455) had met their primary endpoints.

EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.

Switching from reference products to biosimilars: the European perspective

The number of biosimilars receiving marketing authorization has grown steadily over the past several years [1, 2] and is expected to continue growing in the future. Particularly when biologicals are prescribed for the treatment of chronic diseases, switching patients from the originator biological to the biosimilar is increasingly becoming an option, allowing for a considerable reduction of public health expenditure. This article [3] provides an overview of current approaches in Europe to switching patients to treatment with biosimilars.

Comparative results for CT-P10 in low-tumour burden FL

According to research in patients with low-tumour burden follicular lymphoma (FL), the efficacy and pharmacokinetics of rituximab biosimilar CT‑P10 are equivalent or non-inferior to the originator rituximab, Roche’s MabThera/Rituxan [1].