Biosimilars/News
FDA approves pegfilgrastim and rituximab biosimilars
The US Food and Drug Administration (FDA) has approved the pegfilgrastim biosimilar Fylnetra (pegfilgrastim-pbbk) and the rituximab biosimilar Riabni (rituximab-arrx).
Byooviz: first ophthalmology biosimilar launches in US
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.
Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal
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
Canada approves five biosimilars in last seven months
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.
Lucentis biosimilars approved in the UK and Korea
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).
New adalimumab biosimilars prepare to launch in Canada, US and Europe
Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.
FDA approves Amneal’s bevacizumab biosimilar
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.
Europe: positive opinion for Inpremzia and Truvelog Mix 30 and Stimufend authorized
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.
FDA approves Kashiv Biosciences’ filgrastim 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).
Celltrion updates on Remsima and Yuflyma
South Korean biotechnology company Celltrion announced two new data sets on the subcutaneous formulation Remsima (infliximab) in a number of conditions in March 2022. This followed the February 2022 announcement that the high-concentration version of Celltrion’s autoimmune disease biosimilar Yuflyma (adalimumab) has received approval from the European Commission.
