Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Nov 2023
Sandoz launches Hyrimoz (adalimumab) high concentration formulation in Europe, aiming to improve patient care
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
Posted by Michael Wonder on 20 Nov 2023
Teva announces approval of a generic version of Forteo (teriparatide injection) in the US
17 November 2023 - Forteo (teriparatide injection) is indicated to treat osteoporosis among certain women and men.
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Posted by Michael Wonder on 14 Nov 2023
Biocon Biologics receives UK (MHRA) approval for Yesafili, biosimilar aflibercept
13 November 2023 - Biocon Biologics has announced that MHRA in the UK has granted marketing authorisation for Yesafili, a biosimilar ...
Posted by Michael Wonder on 13 Nov 2023
In shocking reversal, CMS wants to allow Medicare Part D plan sponsors to substitute non-interchangeable biosimilars
10 November 2023 - On November 6, 2023, CMS announced a proposed Rule that would permit Medicare Part D plan sponsors ...
Posted by Michael Wonder on 10 Nov 2023
STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...