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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 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. ...
Posted by Michael Wonder on 22 Dec 2024
Dong-A ST secures European approval for Stelara biosimilar Imuldosa
19 December 2024 - Global market expansion accelerates with back to back FDA and EC authorisations. ...
Posted by Michael Wonder on 16 Dec 2024
EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara
15 December 2024 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of Yesintek, ...
Posted by Michael Wonder on 15 Nov 2024
Sandoz receives European Commission approval for Afqlir (aflibercept), further strengthening leading biosimilar portfolio
15 November 2024 - Afqlir (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration. ...
Posted by Michael Wonder on 05 Nov 2024
European Medicines Agency confirms acceptance of marketing authorisation application for AVT05, a proposed biosimilar to Simponi (golimumab)
4 November 2024 - Alvotech and Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT05, ...
Posted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 11 Oct 2024
EMA confirms acceptance of marketing application for AVT03, a proposed biosimilar to Prolia and Xgeva
10 October 2024 - Alvotech announced today that the EMA has accepted a marketing authorisation application for AVT03, a proposed biosimilar ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Celltrion’s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for the treatment of multiple chronic inflammatory diseases
25 August 2024 - The European Commission approval is based on the totality of evidence including the results from a Phase ...
Posted by Michael Wonder on 16 Aug 2024
EMA confirms acceptance of marketing application for AVT06, a proposed biosimilar to Eylea (aflibercept)
15 August 2024 - The approvals process is anticipated to be completed in the third quarter of 2025. ...