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