Biosimilars
Pfizer launching biosimilars in US and Japan but not in EU
In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.
Relative bioavailability of FKB327 when administered using different methods
FKB327 is a biosimilar of Humira (adalimumab), a recombinant, human immunoglobulin G1 monoclonal antibody specific for human tumour necrosis factor alpha (TNF-α). The European Medicines Agency approved FKB327, as Hulio, in 2018 [1].
Phase III trial started in China for eculizumab copy biological
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is starting a phase III clinical trial in China for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).
Achieving fairer prices for generics and biosimilars
Access to safe, effective, quality assured, and affordable essential medicines and vaccines for all has been identified as key to achieving universal health coverage and financial protection. However, this is not always the case, according to Alessandra Ferrario and colleagues from the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Healthcare Institute, Boston, USA [1].
Key issues for adalimumab biosimilars
Adalimumab is a popular and effective antibody treatment for inflammatory bowel disease (IBD). A recent position statement from the Belgian IBD research group (BIRD) reviews key issues surrounding the use of adalimumab biosimilars, including extrapolation, immunogenicity and switching [1].
EMA approval for rituximab biosimilar Ruxience
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab biosimilar Ruxience.
Failures when switching patients to biosimilar etanercept
A ‘real-world’ study on switching patients from the originator etanercept, Enbrel, to the biosimilar Benepali (SB4) investigated the reasons why some patients switched back to the originator [1].
Rituximab biosimilar ABP 798 submitted to FDA
US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration (FDA) for review.
Law and ethics of switching to biosimilars in Canada
With healthcare budgets in mind, governments and financial institutions across the globe are planning or implementing non-medical or ‘forced’ switches by cutting drug coverage for reference biologicals and funding only less expensive biosimilars. This is a subject fraught with issues related to both the law and the ethics of switching. Authors Blake Murdoch and Timothy Caulfield of the Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta, Canada, try to address how such issues might affect Canada [1].
Biosimilars applications under review by EMA – January 2020
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.
