Biosimilars

Hepatobiliary events similar for SB4 and Enbrel in IJD

Biosimilars/Research | Posted 29/05/2020

According to a study carried out by researchers from Denmark, hepatobiliary adverse events occur at a similar frequency in patients treated with the etanercept biosimilar Benepali (SB4) compared to the originator product, Enbrel, in inflammatory joint disease (IJD) [1].

EU approves Henlius copy biologicals facility in China

Biosimilars/General | Posted 29/05/2020

Following European Union (EU) inspections of Shanghai Henlius Biotech, Inc’s Xuhui facility in China, it is likely that the copy biologicals produced at the site will soon be available internationally.

Trials of ustekinumab biosimilars advance

Biosimilars/News | Posted 29/05/2020

Japan-based Meiji Seika Pharma, together with the South Korean company Dong-A, have begun a phase I trial for their ustekinumab biosimilar. Meanwhile, the Australian firm NeuClone has reported results from the phase I trial of its ustekinumab biosimilar, NeuLara.

Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?

Biosimilars/Research | Posted 22/05/2020

Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently potentially influencing launch dates of competitor products, such as biosimilars [2]. In addition, the launch date of a biosimilar might be affected by strategies for prolongation of exclusivity rights on the originator product, such as filing additional patents for a new formulation, new indication or new dosage regime [3].

Canada approves rituximab biosimilars Riximyo and Ruxience

Biosimilars/News | Posted 22/05/2020

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Reimbursement of biosimilars in the US

Biosimilars/General | Posted 22/05/2020

Barriers to market uptake of biosimilars in the US include biosimilars pricing, legal and promotional wars being waged by originator companies, and the lack of confidence in biosimilars [1, 2].

Amgen on both sides of the biosimilar arena

Biosimilars/General | Posted 22/05/2020

Amgen has both originator biologicals and also biosimilars in its portfolio, which means the US-based drugmaker can be on both sides of the fence when it comes to biosimilars.

EMA recommends approval of Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 15/05/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 30 April 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Scientific evidence in development of trastuzumab biosimilar ABP 980

Biosimilars/Research | Posted 15/05/2020

ABP 980 (Kanjinti) is a biosimilar to trastuzumab reference product (RP) (Herceptin), a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2). A biosimilar is highly similar to a licensed biological with no clinically meaningful differences in safety, purity and potency [1, 2]. Kanjinti is approved in the US, European Union, and as trastuzumab BS [trastuzumab biosimilar 2] in Japan for all Herceptin indications, which include treatment of HER2 positive (HER2+) metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer [3-5]. Development and approval were based on a totality of evidence (TOE) approach, involving stepwise generation of comparative analytical (structural and functional), preclinical, and clinical (pharmacokinetics [PK], pharmacodynamics [PD], efficacy, safety and immunogenicity) evidence [6].

Biosimilar education gaps in oncology

Biosimilars/Research | Posted 15/05/2020

A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a biosimilar to an originator and how to manage switching [1].

US FDA clears Biocon manufacturing sites in Malaysia and India

Biosimilars/General | Posted 15/05/2020

There has been successful closure of US Food and Drug Administration (FDA) inspections at Biocon Biologics sites in Malaysia and India. Three manufacturing sites were issued FDA establishment inspection reports (EIRs) in April 2020. The site in Malaysia is set to produce insulin glargine biosimilar, and two sites in Bangalore, India are set to manufacture trastuzumab and pegfilgrastim oncology biosimilars.

Pegfilgrastim biosimilar Fulphila launched in Canada

Biosimilars/News | Posted 08/05/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

How to make biological drugs more affordable

Biosimilars/Research | Posted 08/05/2020

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].

Online education for diabetes specialists on biosimilar insulins

Biosimilars/General | Posted 08/05/2020

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

Celltrion files application with EMA for adalimumab biosimilar

Biosimilars/News | Posted 08/05/2020

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

Non-innovator biologicals in India: regulatory context and areas for improvement

Biosimilars/Research | Posted 04/05/2020

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia

Biosimilars/News | Posted 04/05/2020

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.