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RSS FeedPosted 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16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...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 ...
Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
Posted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...
Posted by Michael Wonder on 04 Apr 2022
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
1 April 2022 - Celerity Pharmaceuticals Uses Biocon Biologics’ Insulin Drug Substance to Develop the Product. ...
Posted by Michael Wonder on 22 Feb 2022
Celltrion's auto-immune disease biosimilar wins further approval in Europe
22 February 2022 - South Korean pharmaceutical giant Celltrion said Tuesday that a high concentration version of its auto-immune disease ...
Posted by Michael Wonder on 16 Dec 2021
AVT02, Alvotech’s biosimilar to high concentration formulation of adalimumab (Humira) approved for use in European Union
15 December 2021 - Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira (adalimumab), from the ...
Posted by Michael Wonder on 14 Oct 2021
Celltrion applies for product approval for Avastin biosimilar in EU
12 October 2021 - Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin ...