25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a ...
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...
27 December 2023 - Formycon and its license partner Klinge Biopharma announce that the EMA has accepted the marketing authorisation application ...
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
20 September 2023 - Biocon Biologics, a subsidiary of Biocon, has announced that the European Commission granted marketing authorisation in ...
19 September 2023 - Tyenne is the first tocilizumab biosimilar approved by the European Commission. ...
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
24 July 2023 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of ...
24 July 2023 - Positive CHMP opinion based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, ...