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RSS FeedPosted by Michael Wonder on 30 Mar 2025
EMA validates Henlius and Organon filing for Perjeta (pertuzumab) biosimilar candidate HLX11
28 March 2025 - -Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation application for ...
Posted by Michael Wonder on 28 Mar 2025
Richter announces submission to EMA for biosimilar tocilizumab in multiple indications
27 March 2025 - Gedeon Richter announces today that the EMA has accepted Richter’s marketing authorisation application for its proposed biosimilar ...
Posted by Michael Wonder on 28 Mar 2025
Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement
27 March 2025 - Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia (denosumab) ...
Posted by Michael Wonder on 20 Mar 2025
Alvotech and Dr. Reddy’s announce FDA acceptance of biologic license application for AVT03, a proposed biosimilar to Prolia and Xgeva
18 March 2025 - Dr. Reddy’s Laboratories and Alvotech today announced that the US FDA has accepted a 351(k) biologic license ...
Posted by Michael Wonder on 18 Mar 2025
Pfizer's Ixifi will be available in Canada as of 1 April 2025
17 March 2025 - Ixifi is available in more than 20 countries and was approved by Health Canada in December 2021. ...
Posted by Michael Wonder on 12 Mar 2025
Celltrion's infliximab, the first monoclonal antibody biosimilar, is now Remdantry in Canada
11 March 2025 - CT-P13, intravenous infliximab, developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar therapy and has ...
Posted by Michael Wonder on 10 Mar 2025
US FDA approves Celltrion's Omlyclo (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing Xolair
9 March 2025 - Regulatory approval for interchangeability was supported by positive Phase 3 data demonstrating comparable efficacy and safety profile ...
Posted by Michael Wonder on 05 Mar 2025
Celltrion receives US FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva
3 March 2025 - The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the ...
Posted by Michael Wonder on 04 Mar 2025
Amneal’s BLA submissions for two denosumab biosimilars accepted for review by US FDA
3 March 2025 - Denosumab biosimilar candidates reference Prolia and Xgeva. ...
Posted by Michael Wonder on 27 Feb 2025
Kashiv BioSciences obtains marketing authorisation for pegfilgrastim injection from Health Canada
25 February 2025 - Kashiv BioSciences today announced that Health Canada has granted marketing authorisation for its pegfilgrastim injection, enabling its ...
Posted by Michael Wonder on 21 Feb 2025
Alvotech and Teva announce filing acceptance of US biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept)
18 February 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review a biologics license ...
Posted by Michael Wonder on 19 Feb 2025
European Commission approves Biocon Biologics’ ustekinumab biosimilar
18 February 2025 - Biocon announced today that the European Commission granted marketing authorisation in the European Union for Yesintek, ...
Posted by Michael Wonder on 17 Feb 2025
Samsung Bioepis gains European Commission approval for denosumab biosimilar (Obodence, Xbryk)
16 February 2025 - Obodence and Xbryk approved by the European Commission for all indications referencing Prolia and Xgeva, respectively. ...
Posted by Michael Wonder on 16 Feb 2025
FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva
15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...