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RSS FeedPosted by Michael Wonder on 09 Jun 2026
Alvotech announces FDA acceptance of biologics license application for AVT16, a proposed interchangeable biosimilar to Entyvio
8 June 2026 - Alvotech today announced that the US FDA has accepted for review a biologics license application for ...
Posted by Michael Wonder on 07 Jun 2026
Boan Biotech submits a biologics license application for two denosumab biosimilars in the US
29 May 2026 - Boan Biotech announced today that it has submitted a biologics license application to the US FDA for ...
Posted by Michael Wonder on 05 Jun 2026
Kashiv BioSciences announces validation and acceptance of market authorisation application by Health Canada for ADL-018, a proposed biosimilar to Xolair (omalizumab)
4 June 2026 - Kashiv BioSciences today announced that Health Canada has validated and accepted the marketing authorisation application for ADL-018, ...
Posted by Michael Wonder on 05 Jun 2026
Teva expands European biosimilars portfolio with launch of Ahzantive (aflibercept) biosimilar to Eylea
4 June 2026 - Teva Pharmaceutical Industries today announced the launch of Ahzantive (aflibercept), a biosimilar to Eylea, in Europe further ...
Posted by Michael Wonder on 03 Jun 2026
Celltrion files for approval of Cosentyx biosimilar, CT-P55, in Canada
1 June 2026 - Celltrion announced on Monday that it has submitted a regulatory application to Health Canada for CT-P55, ...
Posted by Michael Wonder on 19 May 2026
FDA approves Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), first biosimilars to Simponi (golimumab) and Simponi Aria (golimumab)
18 May 2026 - Accord BioPharma announced today that the US FDA has approved Immgolis (golimumab-sldi), a biosimilar to Simponi ...
Posted by Michael Wonder on 15 May 2026
Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes
15 May 2026 - Sandoz today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda ...
Posted by Michael Wonder on 30 Apr 2026
Xbrane submits ranibizumab biosimilar candidate to FDA
29 April 2026 - Xbrane Biopharma has submitted an application for approval to the US FDA for its biosimilar candidate ...
Posted by Michael Wonder on 30 Apr 2026
European Commission approves Henlius and Organon's Poherdy (pertuzumab), the first approved biosimilar to Perjeta (pertuzumab) in Europe
29 April 2026 - Shanghai Henlius Biotech, and Organon today announced the European Commission has granted marketing authorization for Poherdy (pertuzumab) ...
Posted by Michael Wonder on 30 Apr 2026
Richter receives European Commission approval for Tuyory, its biosimilar tocilizumab in multiple indications
29 April 2026 - Gedeon Richter announces today that the European Commission granted marketing authorisation for Tuyory, its biosimilar to ...
Posted by Michael Wonder on 22 Apr 2026
Biocon receives Health Canada approval of Bosaya (denosumab) and Vevzuo (denosumab), biosimilars to Prolia and Xgeva
21 April 2026 - Biocon is pleased to announce that Health Canada has granted a Notice of Compliance for Bosaya (denosumab), ...
Posted by Michael Wonder on 08 Apr 2026
Apotex strengthens osteoporosis care in Canada with Health Canada's approval of Denoza, a denosumab biosimilar
7 April 2026 - Apotex today announced that Health Canada has approved Denoza (denosumab injection), a biosimilar to Prolia, for its ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 09 Mar 2026
FDA takes further steps to streamline biosimilar development and make medicines more affordable
9 March 2026 - The US FDA today announced another major step in its initiative to streamline the development of biosimilar ...
Posted by Michael Wonder on 01 Mar 2026
EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11
27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the ...