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RSS FeedPosted 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 03 Feb 2025
US FDA accepts biologics license application for HLX11, biosimilar candidate of Perjeta (pertuzumab)
2 February 2025 - Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for HLX11, ...
Posted by Michael Wonder on 02 Feb 2025
US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra
30 January 2025 - Approval was received for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic ...
Posted by Michael Wonder on 29 Jan 2025
Alvotech and Teva announce filing acceptance of US biologics license applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab)
27 January 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review biologics license applications ...
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 09 Jan 2025
Fresenius Kabi Canada has received a Health Canada Notice of Compliance for Otulfi an ustekinumab biosimilar
8 January 2025 - Otulfi received a Health Canada Notice of Compliance approval on 30 December 2024 for both subcutaneous and ...
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 18 Dec 2024
US FDA approves Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab)
17 December 2024 - Steqeyma is expected to be marketed in the US in February 2025. ...
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 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 11 Dec 2024
Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada
9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...
Posted by Michael Wonder on 10 Dec 2024
PHARMAC seeks feedback to fund medicines for liver and ovarian cancer
9 December 2024 - PHARMAC is consulting on a proposal to fund bevacizumab (branded as Vegzelma) as a cancer medicine ...
Posted by Michael Wonder on 07 Dec 2024
US FDA approves Biocon Biologics' Yesintek biosimilar to J&J's Stelara (ustekinumab)
2 December 2024 - Biocon Biologics announced today that the US FDA has approved Yesintek (ustekinumab-kfce), a biosimilar to the ...
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, ...