The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.
The US Food and Drug Administration (FDA) has approved the pegfilgrastim biosimilar Fylnetra (pegfilgrastim-pbbk) and the rituximab biosimilar Riabni (rituximab-arrx).
Biogen and Samsung Bioepis have launched Byooviz (ranibizumab-nuna) on the US market as the first ophthalmology biosimilar. It references Roche’s (Genentech’s) blockbuster therapy, Lucentis.
In May 2022, Biocon Biologics launched a bevacizumab biosimilar co-developed with Viatris (formerly Mylan), in Canada; and in April 2022, Biocon was awarded a three-year contract, worth US$90 million, by Malaysia's Ministry of Health
Since November 2021, Canada’s drug regulator, Health Canada, has approved no less than five biosimilars for the treatment of diabetes, cancer, osteoporosis and autoimmune conditions.
The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and South Korea’s Ministry of Food and Drug Safety have approved biosimilar versions of Genentech’s ophthalmology drug, Lucentis (ranibizumab).
Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.
The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ (Amneal) bevacizumab biosimilar, Alymsys, the third bevacizumab biosimilar to be approved in the US.
On 28 March 2022, the European Commission (EC) has granted marketing authorization for Fresenius Kabi's oncology biosimilar, Stimufend (pegfilgrastim); and the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2022 that it had recommended granting of marketing authorization for an insulin aspart biosimilar and an insulin human (rDNA) biosimilar.
The US Food and Drug Administration (FDA) has approved a filgrastim biosimilar produced by India-based Kashiv Biosciences. The biosimilar will be marketed under the trade name Releuko (filgrastim-ayow).