Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 01 Aug 2024
Prestige Biopharma's Herceptin biosimilar Tuznue receives positive CHMP opinion from the EMA
31 July 2024 - Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue would become the first biosimilar from ...
Posted by Michael Wonder on 31 Jul 2024
EMA approves Bio-Thera Solutions' BAT1706 (Avzivi, bevacizumab), a biosimilar referencing Avastin
30 July 2024 - Bio-Thera Solutions today announced that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin. ...
Posted by Michael Wonder on 26 Jul 2024
Sandoz launches biosimilar Pyzchiva (ustekinumab) across Europe, to treat chronic inflammatory diseases
25 July 2024 - Pyzchiva first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130 mg vial ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...
Posted by Michael Wonder on 02 Jul 2024
Altos Biologics files for approval of aflibercept biosimilar
1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...
Posted by Michael Wonder on 26 Jun 2024
Tofidence (tocilizumab), a biosimilar referencing RoActemra, approved in the European Union
24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...