Biosimilars/News
Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin
On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16 September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).
FDA approves biosimilar pegfilgrastim Stimufend
On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).
EC approves bevacizumab biosimilar Vegzelma
On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.
FDA accepts application for high concentration adalimumab biosimilar
Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).
EC approves ranibizumab biosimilar Ranivisio
On 29 August 2022, the ranibizumab biosimilar Ranivisio (FYB201), developed by Bioeq – a joint venture between Formycon and Polpharma Biologics, was granted marketing approval by the European Commission (EC).
Applications for natalizumab biosimilars accepted by FDA and EMA
Applications for natalizumab biosimilars made by Sandoz (the generics division of Novartis) and Polpharma Biologics (Polpharma) have been accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
FDA accepts application for tocilizumab biosimilar
Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 1 August 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed tocilizumab biosimilar (MSB11456).
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).
