Blog
RSS FeedPosted by Michael Wonder on 20 Feb 2024
Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis
20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...
Posted by Michael Wonder on 19 Feb 2024
Health Canada approves Remsima SC for the treatment of inflammatory bowel disease
18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...
Posted by Michael Wonder on 14 Feb 2024
Celltrion seeks European approval for Actemra biosimilar
13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a ...
Posted by Michael Wonder on 05 Feb 2024
Medicare patient access to Humira biosimilars still falls woefully short
5 February 2024 - According to a Federal Government Medicare Payment Advisory Commission report published last month, more than 40% of ...
Posted by Michael Wonder on 29 Jan 2024
Celltrion USA completes submission of biologics license application for CT-P47, a biosimilar candidate of Actemra (tocilizumab)
28 January 2024 - The biologics license application for CT-P47 was based on Phase III data comparing CT-P47 to the ...
Posted by Michael Wonder on 11 Jan 2024
STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...
Posted by Michael Wonder on 05 Jan 2024
Accord BioPharma announces US FDA acceptance of biologics license application for proposed Stelara biosimilar DMB-3115
4 January 2024 - Biosimilar for Stelara (ustekinumab) seeks to treat several auto-immune disorders caused by overactive immune response. ...
Posted by Michael Wonder on 05 Jan 2024
CVS will remove AbbVie's Humira from some drug reimbursement lists in April
4 January 2024 - CVS Health said on Wednesday it will remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some ...
Posted by Michael Wonder on 28 Dec 2023
Celltrion seeks approval for Xolair biosimilar in Canada
27 December 2023 - Celltrion said Wednesday that it has completed the submission of its marketing authorisation application for its ...
Posted by Michael Wonder on 28 Dec 2023
Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 December 2023 - Formycon and its license partner Klinge Biopharma announce that the EMA has accepted the marketing authorisation application ...
Posted by Michael Wonder on 08 Dec 2023
FDA Approves Bio-Thera Solutions' Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin
7 December 2023 - Avzivi is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA ...
Posted by Michael Wonder on 08 Dec 2023
Health Canada approves FYB201/Ranopto (ranibizumab), a biosimilar to Lucentis
7 December 2023 - Formycon, Polpharma Biologics, Bioeq and Teva Canada jointly announce that Health Canada has granted the Notice ...
Posted by Michael Wonder on 04 Dec 2023
Celltrion submits application for FDA approval of Prolia biosimilar CT-P41
4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing ...
Posted by Michael Wonder on 30 Nov 2023
Formycon and Fresenius Kabi announce file acceptance for FYB202, a biosimilar candidate to Stelara (ustekinumab), by the US FDA
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...
Posted by Michael Wonder on 27 Nov 2023
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...