Biosimilars

Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal

Biosimilars/General | Posted 06/09/2019

After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbrel, Sandoz says it will appeal the ruling, which prevents the launch of its biosimilar Erlezi.

Positive results for Bio-Thera’s arthritis copy biologicals

Biosimilars/Research | Posted 06/09/2019

China-based Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive results from a phase III trial of its Humira copy biological.

Mylan launches adalimumab biosimilar Hulio in Spain

Biosimilars/News | Posted 06/09/2019

US-based drugmaker Mylan announced on 9 July 2019 the launch of its adalimumab biosimilar, Hulio, in Spain; the company’s first biosimilar in the country.

Perceptions of biosimilars among US cancer patients

Biosimilars/Research | Posted 30/08/2019

Amid increasingly expensive cancer treatments, researchers in the US explored perceptions of generic drugs among a group of 75 patients, in findings presented alongside the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Heparin biosimilar to be marketed in Canada

Biosimilars/News | Posted 30/08/2019

Canadian pharmaceuticals firm Valeo Pharma Inc has been given the rights to market a biosimilar version of low molecular weight heparin (LMWH), which is used to prevent blood clots in a range of conditions.

Momenta drops Humira biosimilar development

Biosimilars/General | Posted 30/08/2019

Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab). However, they will continue to develop other biosimilar products.

Comparison of darbepoetin alfa and epoetin alfa for the treatment of renal anaemia

Biosimilars/Research | Posted 30/08/2019

Darbepoetin alfa (DA-α) manufactured by Hetero Biopharma (Hetero) is the first long-acting erythropoiesis-stimulating agent with extended dosing intervals. This gives it an advantage over epoetin alfa (EPO) and epoetin beta. It also has a half-life three-fold longer than that of EPO.

Trastuzumab biosimilar to be distributed by Mundipharma

Biosimilars/News | Posted 30/08/2019

Singapore-based Prestige BioPharma’s (Prestige) trastuzumab biosimilar Tuznue (HD201) will be distributed in selected European markets exclusively by UK-based Mundipharma International (Mundipharma) and its independent associated companies. Tuznue is a biosimilar of Roche’s Herceptin (trastuzumab) which is used to treat patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Mylan launches first trastuzumab biosimilar in Australia

Biosimilars/News | Posted 23/08/2019

Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.

Samsung Bioepis starts phase III trial for eculizumab copy biological

Biosimilars/News | Posted 23/08/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Australia approves three biosimilars in first half of 2019

Biosimilars/General | Posted 23/08/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzumab biosimilars and an adalimumab biosimilar.

Safety of SC form of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 23/08/2019

Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

FDA approves adalimumab biosimilar Hadlima

Biosimilars/News | Posted 16/08/2019

Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5).

Korean firms to launch biosimilars in Japan despite trade tensions

Biosimilars/News | Posted 16/08/2019

Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second half of 2019.

Biosimilars applications under review by EMA – July 2019

Biosimilars/General | Posted 16/08/2019

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.

Positive phase III results for bevacizumab copy biological IBI305

Biosimilars/Research | Posted 16/08/2019

Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Extensive characterization of biosimilars: a pegylated filgrastim study

Biosimilars/Research | Posted 16/08/2019

Pegfilgrastim, is a 38 kDa, pegylated form of filgrastim, with a 20 kDa monomethoxypolyethylene glycol (mPEG) molecule covalently bound to the N-terminal methionyl residue of filgrastim developed by Amgen. Attachment of the mPEG-moiety enables a longer half-life, that enables only once-per-cycle administration for the management of chemotherapy-induced neutropenia. This results in a much simpler treatment regime for patients. The biosimilar version of pegfilgrastim developed by Intas Pharmaceuticals, and marketed by Accord Healthcare under the brand name Pelgraz, is one of the first pegfilgrastim biosimilars to be approved for market authorization in the European Union (EU) [1].

Distinct suffixes will aid biosimilar competition, says new research

Biosimilars/Research | Posted 09/08/2019

The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].

EMA accepts first application for Chinese-made biosimilar HLX02

Biosimilars/News | Posted 09/08/2019

China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).

South Korea’s Celltrion to sell directly to Australia

Biosimilars/General | Posted 09/08/2019

In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.

Rituximab copy biological accepted for review in China

Biosimilars/News | Posted 09/08/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.

Real-world data on switching of etanercept biosimilars

Biosimilars/Research | Posted 09/08/2019

Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

FDA approves rituximab biosimilar Ruxience

Biosimilars/News | Posted 02/08/2019

US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar (PF 05280586).

Long-term safety results for adalimumab biosimilar

Biosimilars/Research | Posted 02/08/2019

ABP 501 is an adalimumab biosimilar which was compared to reference adalimumab in a 24-week phase lll study demonstrating equivalent efficacy and similar safety and immunogenicity [1]. The results of this clinical trial, along with the totality of evidence from analytical and biofunctional evaluation, lead to the approval of this adalimumab biosimilar for rheumatoid arthritis in the European Union and the US. ABP 501 is marketed as Amgevita in Europe and other markets. However, it will not be available in the US until 2023 due to an agreement between Amgen, the developer of the biosimilar, and AbbVie who manufactures the originator product, Humira (adalimumab) [2].

Positive phase III data for adalimumab copy biologicals

Biosimilars/Research | Posted 02/08/2019

Positive phase III data for adalimumab copy biologicals has been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Lannett starts phase I trial for insulin glargine biosimilar in South Africa

Biosimilars/News | Posted 02/08/2019

US generics maker Lannett Company (Lannett) announced on 5 June 2019 that it had started a phase I clinical trial of its candidate insulin glargine biosimilar.

NHS England updates its ‘What is a Biosimilar Medicine?’

Biosimilars/General | Posted 02/08/2019

The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.

EMA accepts application for bevacizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 26/07/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 19 July 2019 that the application for approval for its proposed bevacizumab biosimilar SB8 has been accepted for review by the European Medicines Agency (EMA).

Positive results for rituximab non-originator and copy biologicals

Biosimilars/Research | Posted 26/07/2019

Positive results for the rituximab non-originator biological BCD-020 (AcellBia) and for the rituximab copy biological HLX01 (Hanlikon) have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1, 2].

Positive phase III results for trastuzumab biosimilar HD201

Biosimilars/Research | Posted 26/07/2019

Singapore-based Prestige BioPharma (Prestige) announced on 24 June 2019 positive phase III data for its trastuzumab biosimilar, HD201. The results, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’.

South Korea increases investment in biologicals

Biosimilars/General | Posted 26/07/2019

Investment in the biotech sector is ramping up in South Korea, with increased state-led support and private sector pledges.

Sandoz to start phase III trial for denosumab biosimilar

Biosimilars/News | Posted 26/07/2019

Sandoz, the generics division of Novartis, is planning to start a phase III trial for its candidate denosumab biosimilar GP2411 in patients with post-menopausal osteoporosis in collaboration with Germany-based biosimilars maker Hexal.

FDA approves bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 19/07/2019

US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its bevacizumab biosimilar Zirabev (PF-06439535).

Real-world data confirms safety of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 19/07/2019

Positive real-world data has been presented for Celltrion’s infliximab biosimilar CT P13 at the European Congress of Rheumatology 2019 (EULAR 2019).

Clinical and real-world data for switching to biosimilars

Asian specialists' recommendations for off-patent biologicals in IBD

Biosimilars/Research | Posted 19/07/2019

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].

Positive phase III results for trastuzumab follow-on biological Zedora

Biosimilars/Research | Posted 19/07/2019

Results of a post-marketing study of Biocon and Mylan’s trastuzumab biosimilar Zedora (MYL-1401O) compared to Herceptin (trastuzumab) has shown equivalent safety data to the originator biological in breast and gastric cancer, according to the authors [1].

How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden

Biosimilars/Research | Posted 21/06/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Member States are responsible for pricing, reimbursement and policies on market entry and use of medicines. This decentralized responsibility results in diverging approaches towards market entry and uptake of biosimilars and contributes to variation in the use of biosimilars across European countries, and even within countries differences in biosimilar uptake levels exist. The latter is the case for the 21 counties of Sweden, implying that decisions taken by their county councils play a role in market access of biosimilars, alongside policy measures and incentives provided at the national level.