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RSS FeedPosted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
Posted by Michael Wonder on 29 Sep 2025
EMA recommends marketing approval of Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab) with Advanz Pharma as commercialisation partner
22 September 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 23 Sep 2025
EMA recommends marketing authorisation of AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva
22 September 2025 - Alvotech today announced that the EMA's CHMP has adopted a positive opinion recommending approval for AVT03, Alvotech’s ...
Posted by Michael Wonder on 18 Sep 2025
Alteogen receives European Commission approval for aflibercept biosimilar, Eyluxvi (ALT-L9)
17 September 2025 - Eyluxvi is the second biosimilar approved for Alteogen following the launch of the Herceptin biosimilar in China ...
Posted by Michael Wonder on 29 Jul 2025
Alteogen receives positive CHMP opinion for aflibercept biosimilar, 'Eyluxvi (ALT-L9)'
28 July 2025 - Upon approval, Eyluxvi will be Alteogen's second biosimilar product, following a Herceptin biosimilar by Alteogen's license ...
Posted by Michael Wonder on 29 Jul 2025
CHMP recommends EU approval of Henlius’ denosumab biosimilar HLX14
28 July 2025 - Shanghai Henlius Biotech announced today that the EMA's CHMP has adopted a positive opinion for HLX14, the ...
Posted by Michael Wonder on 05 Jul 2025
European Commission approves Biocon biologics’ denosumab biosimilars
3 July 2025 - Biocon Biologics today announced that the European Commission has granted marketing authorisation in the European Union ...
Posted by Michael Wonder on 24 Jun 2025
EMA recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept)
23 June 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP adopted a positive opinion recommending approval for ...
Posted 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 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 08 Feb 2025
Bio-Thera Solutions announces regulatory filing acceptance for BAT2506, a proposed biosimilar to Simponi, in the European Union
7 February 2025 - The BAT2506 marketing authorisation application is based on a robust analytical, non-clinical and clinical data package comparing ...
Posted by Michael Wonder on 21 Jan 2025
Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama
20 January 2025 - Teva Pharmaceuticals will semi-exclusively market FYB203 under the brand name Ahzantive in major parts of Europe. ...