In more than 10 years of clinical experience, no substantial clinical and safety differences have been detected among biosimilars and their already approved biologicals [1]. However, concerns are raised with respect to the practice of switching in patients already treated with a specific biological product (either reference or biosimilar) [2].

To date (7 May 2021), the US Food and Drug Administration (FDA) has approved 29 biosimilars, plus four follow-on biologicals [1]. The pipeline for biosimilars continues to grow, however, of the 29 biosimilars approved, only 20 have so far been launched [2].

If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.

The first approved bevacizumab biosimilar, ABP 215 (Mvasi), can be prepared in- bag, over a month prior to being used to treat patients via intravenous (IV) infusion, shows a study published in GaBI Journal [1]. The study reveals that ABP 215 retains physicochemical stability after dilution and storage, which can ease the process of drug administration in clinical settings.

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 29 March 2021 that it had now launched its adalimumab biosimilar, Hadlima (SB5), in Australia and Canada.

An assessment of insurer formularies for pegfilgrastim in the US suggests that payer-imposed preferences increase complexity when pharmacists and physicians are choosing which version of a drug to stock and administer.  

The European Medicines Agency’s (EMA) Committee for Medical Products for Huan Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.

On 25 April 2021, Danish drug company Lundbeck and four generic drugmakers lost their appeal against European Union antitrust fines of Euros 146 million (US$172 million), imposed in 2013.

The US is keeping pace with the European pioneers of biosimilars approvals, reveals an article published in GaBI Journal [1].

Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).