14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase III trial. ...
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
30 May 2023 - Samsung Bioepis said that the European Commission has granted marketing authorization for Epysqli, a biosimilar referencing ...
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
3 April 2023 - Biosimilar Hyrimoz (adalimumab) citrate free high concentration formulation is now approved in the EU for use in ...
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
9 February 2023 - EMA opinion on AVT04 could come as soon as the second half of 2023. ...
30 January 2023 - Sandoz is seeking approval of high concentration formulation adalimumab for use in all indications of reference medicine. ...
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
29 August 2022 - Formycon, Polpharma Biologics and Bioeq jointly announce that the European Commission has granted marketing authorisation for ...
18 August 2022 - Vegzelma offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical ...