1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
19 April 2024 - Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to ...
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
17 March 2024 - Zymfentra is commercially available across the US on 15 March 2024. ...
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
7 March 2024 - Fresenius Kabi announced today that the US FDA has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra ...
5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...
23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
28 January 2024 - The biologics license application for CT-P47 was based on Phase III data comparing CT-P47 to the ...
4 January 2024 - Biosimilar for Stelara (ustekinumab) seeks to treat several auto-immune disorders caused by overactive immune response. ...
7 December 2023 - Avzivi is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA ...
4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing ...
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...