Biosimilars/News
FDA approves first interchangeable ranibizumab biosimilar
Polpharma Biologics, Formycon and Bioeq jointly announced on 2 August 2022 that they had received approval from the US Food and Drug Administration (FDA) for their ranibizumab biosimilar (CHS-201/FYB201).
Innovent-Etana bevacizumab biosimilar approved in Indonesia
Innovent announced the approval of its bevacizumab biosimilar in Indonesia, that was developed in partnership with PT Etana Biotechnologies Indonesia.
Ranibizumab biosimilar, FYB201, receives EMA recommendation
Formycon’s ranibizumab biosimilar, FYB201, has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
New data on infliximab and adalimumab biosimilars at EULAR 2022
The Annual European Congress of Rheumatology (EULAR 2022) was held at the beginning of June 2022. This platform was used to announce the results of a study that showed that, in patients with rheumatoid arthritis, statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab. In addition, Samsung Bioepis announced new data on their established adalimumab biosimilar Imraldi (Hadlima outside Europe).
EMA accepts application for high concentration adalimumab biosimilar
Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).
EMA recommends approval of bevacizumab biosimilar Vegzelma
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.
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.
