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RSS FeedPosted by Michael Wonder on 18 Feb 2026
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications
18 February 2026 - Sandoz today announced that the US FDA has approved an expanded label for Enzeevu (aflibercept-abzv), to include ...
Posted by Michael Wonder on 14 Feb 2026
STADA and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi
13 February 2026 - STADA and Bio-Thera Solutions have received a marketing authorisation from the European Commission for their Gotenfia ...
Posted by Michael Wonder on 02 Feb 2026
Samsung Bioepis to launch Eylea biosimilar Opuviz in Europe
30 January 2026 - Samsung Bioepis said Friday it has reached an agreement with US based firm Regeneron and Germany’s ...
Posted by Michael Wonder on 30 Jan 2026
Celltrion secures Canadian approval for Omlyclo 300 mg PFS and auto-injector formulations
29 January 2026 - Celltrion said Thursday that it has received additional approval from Health Canada for its chronic idiopathic ...
Posted by Michael Wonder on 29 Jan 2026
Dong-A ST receives Health Canada approval for Stelara biosimilar Imuldosa
28 January 2026 - Dong-A ST announced on Wednesday that Health Canada has granted marketing authorisation for Imuldosa (ingredient: ustekinumab), ...
Posted by Michael Wonder on 14 Jan 2026
Sandoz confirms European Commission approval of Ondibta (insulin glargine), strengthening overall biosimilars leadership and position in diabetes
14 January 2026 - Expected launch by early 2027; potential to expand access to insulin treatment option for tens of millions ...
Posted by Michael Wonder on 14 Jan 2026
Henlius' fifth US filing product bevacizumab biosimilar HLX04 receives FDA BLA acceptance
13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar ...
Posted by Michael Wonder on 27 Dec 2025
Amneal announces FDA approval of denosumab biosimilars referencing Prolia and Xgeva
22 December 2025 - Company expects to commercialize six biosimilars across eight presentations by 2027. ...
Posted by Michael Wonder on 24 Dec 2025
Thousands more people with advanced bowel cancer to benefit as NICE approves bevacizumab biosimilars
24 December 2025 - More than 7,000 people in England will now be able to access to a life-extending treatment for ...
Posted by Michael Wonder on 05 Dec 2025
Celltrion announces US FDA approval of 300 mg strength of Omyclo (omalizumab-igec), the first and only FDA approved interchangeable biosimilar to Xolair
1 December 2025 - Celltrion today announced the US FDA has approved a new presentation of Omyclo (omalizumab-igec), the first and ...
Posted by Michael Wonder on 04 Dec 2025
Pre-filled syringe presentation of Byooviz, Samsung Bioepis’ biosimilar to Lucentis (ranibizumab), gains European approval
2 December 2025 - Samsung Bioepis today announced that the EMA’s CHMP has adopted a positive opinion for Byooviz pre-filled syringe, ...
Posted by Michael Wonder on 02 Dec 2025
Samsung Bioepis announces launch of denosumab biosimilars, Obodence and Xbryk in Europe
1 December 2025 - Samsung Bioepis today announced the launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), ...
Posted by Michael Wonder on 28 Nov 2025
Celltrion receives Health Canada approval for Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg)
27 November 2025 - The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global ...
Posted by Michael Wonder on 27 Nov 2025
Alvotech announces approval of AVT03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area
November 24, 2025 - Alvotech today announced that the European Commission has approved AVT03 as a biosimilar to Prolia and ...
Posted by Michael Wonder on 18 Nov 2025
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application ...