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RSS FeedPosted by Michael Wonder on 27 Nov 2023
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
Posted by Michael Wonder on 21 Nov 2023
Sandoz launches Hyrimoz (adalimumab) high concentration formulation in Europe, aiming to improve patient care
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
Posted by Michael Wonder on 10 Nov 2023
STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...
Posted by Michael Wonder on 03 Oct 2023
Formycon and Fresenius Kabi announce EMA acceptance of the marketing authorisation application for FYB202, an ustekinumab biosimilar candidate
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
Posted by Michael Wonder on 26 Sep 2023
Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for multiple sclerosis in Europe
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
Posted by Michael Wonder on 21 Sep 2023
Biocon Biologics receives European Commission approval for Yesafili, biosimilar aflibercept
20 September 2023 - Biocon Biologics, a subsidiary of Biocon, has announced that the European Commission granted marketing authorisation in ...
Posted by Michael Wonder on 20 Sep 2023
Tyenne, Fresenius Kabi’s tocilizumab biosimilar, receives European Commission approval
19 September 2023 - Tyenne is the first tocilizumab biosimilar approved by the European Commission. ...
Posted by Michael Wonder on 18 Sep 2023
Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
Posted by Michael Wonder on 24 Jul 2023
Biocon Biologics announces positive CHMP opinion for Yesafili, biosimilar aflibercept
24 July 2023 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 Jul 2023
Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab
24 July 2023 - Positive CHMP opinion based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, ...
Posted by Michael Wonder on 15 Jul 2023
European Medicine Agency accepts Intas' marketing authorisation application for DMB-3115, a proposed biosimilar to Stelara (ustekinumab)
14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase 3 trial. ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 01 Jun 2023
Samsung Bioepis obtains European Commission approval for Soliris biosimilar
30 May 2023 - Samsung Bioepis said that the European Commission has granted marketing authorization for Epysqli, a biosimilar referencing ...
Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
Posted by Michael Wonder on 26 Apr 2023
Celltrion seeks approval for Xolair biosimilar in EU
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...