Biosimilars
EMA accepts application for ranibizumab biosimilar from Samsung Bioepis
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.
Biosimilar assessments: do we need efficacy trials?
Regulatory guidelines for biosimilar approval have existed in Europe since 2004. These are based on the totality of evidence from comparative studies with reference products and have always required comparative efficacy studies. However, a recent article by Bielsky et al., published in Drug Discovery Today [1], explores the increasingly questioned role of the clinical efficacy trial in biosimilar approval.
Biopharmaceuticals and biosimilars: manufacturing challenges
Biopharmaceuticals include a complex active pharmaceutical ingredient (API). This is manufactured using living systems such as microbial and mammalian cells which makes manufacture a complicated process. A recent paper by Sia et al. published in GaBI Journal [1] has explored current biopharmaceutical processes and the challenges posed by manufacturer.
Biopharmaceuticals and biosimilars: manufacturing processes
The active pharmaceutical ingredient (API) in biopharmaceuticals is manufactured using living systems such as microbial and mammalian cells. Due to this, their manufacture is complex. A recent review by Sia et al. published in GaBI Journal [1] has carried out an in-depth exploration of current biopharmaceutical manufacturing processes.
EC approval for bevacizumab biosimilar Equidacent
Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.
China accepts application for bevacizumab copy biological
The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a bevacizumab copy biological developed by 3SBio and Samsung Bioepis.
Pharmacists are key to quality use of medicines for biosimilars
A commissioned review in The Pharmaceutical Journal [1] on interchangeability of biosimilars highlights the pivotal role pharmacists play in the adoption and appropriate use of biosimilars.
Australian diabetes organizations issue biosimilars position statement
In June 2020, the Australian Diabetes Society, Australian Diabetes Educators Association and Diabetes Australia, published a position statement on the use of biosimilar ‘insulins’ for diabetes.
Clinical review of biosimilars approved in oncology
As cancer therapeutics constitutes a large proportion of the biologicals market, and patents have begun to expire, biosimilars have an important role in optimizing patient access and reducing costs in the oncology therapeutic area. Authors Ngo and Chen from the City of Hope National Medical Center, Los Angeles, USA, give an overview of the US Food and Drug Administration (FDA)-approved biosimilars in oncology and their impact on the healthcare system in the Annals of Pharmacotherapy [1]. A summary of the main findings from that article follows.
Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP
Biopharmaceuticals are large molecules that are far more complex than traditional, chemical pharmaceuticals. With patent expiry for many originators, biosimilar versions are expected to flood the market in the years to come. However, the active pharmaceutical ingredients (APIs) of all such products are manufactured using living systems which means that their manufacture and characterization is also complex.
