Blog

31 July 2024 - Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue would become the first biosimilar from ...

25 July 2024 - Pyzchiva first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130 mg vial ...

24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...

11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...

1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...

24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...

24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...

23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...

22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...

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 ...