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RSS FeedPosted by Michael Wonder on 03 Apr 2023
Sandoz receives approval by European Commission for Hyrimoz (adalimumab) high-concentration formulation
3 April 2023 - Biosimilar Hyrimoz (adalimumab) citrate free high concentration formulation is now approved in the EU for use in ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 09 Feb 2023
EMA confirms acceptance of application for AVT04, a proposed biosimilar to Stelara (ustekinumab)
9 February 2023 - EMA opinion on AVT04 could come as soon as the second half of 2023. ...
Posted by Michael Wonder on 30 Jan 2023
Sandoz receives positive CHMP opinion for citrate free high concentration formulation of adalimumab biosimilar
30 January 2023 - Sandoz is seeking approval of high concentration formulation adalimumab for use in all indications of reference medicine. ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 30 Sep 2022
Biogen announced EMA filing acceptance of BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab)
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...
Posted by Michael Wonder on 19 Sep 2022
Biosimilar medicines can be interchanged
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
Posted by Michael Wonder on 16 Sep 2022
Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
Posted by Michael Wonder on 29 Aug 2022
European Commission approves Ranivisio (ranibizumab), a biosimilar to Lucentis
29 August 2022 - Formycon, Polpharma Biologics and Bioeq jointly announce that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 20 Aug 2022
European Commission approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer
18 August 2022 - Vegzelma offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical ...
Posted by Michael Wonder on 20 Aug 2022
Fresenius Kabi announces acceptance of its marketing authorisation application by the European Medicines Agency for MSB11456, a tocilizumab biosimilar candidate
18 August 2022 - Fresenius Kabi announced today that its marketing authorisation application for MSB11456, the company’s tocilizumab biosimilar candidate, ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 16 Jul 2022
Polpharma Biologics announces EMA acceptance of marketing authorisation application for proposed biosimilar natalizumab
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, ...
Posted by Michael Wonder on 27 Jun 2022
FYB201, Formycon's biosimilar for Lucentis (ranibizumab), receives CHMP recommendation from EMA
24 June 2022 - Formycon and its licensing partner Bioeq announce that the CHMP of the EMA today issued a ...
Posted by Michael Wonder on 27 Jun 2022
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma (CT-P16)
27 June 2022 - The positive opinion is based on the totality of evidence including the Phase III study to evaluate ...