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RSS FeedPosted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
Posted by Michael Wonder on 18 Mar 2024
Zymfentra (infliximab-dyyb), the first and only FDA approved subcutaneous infliximab, now commercially available in the U.S.
17 March 2024 - Zymfentra is commercially available across the US on 15 March 2024. ...
Posted by Michael Wonder on 11 Mar 2024
Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
Posted by Michael Wonder on 09 Mar 2024
Fresenius Kabi’s biosimilar Tyenne (tocilizumab-aazg) becomes the first intravenous and subcutaneous tocilizumab biosimilar approved by the FDA
7 March 2024 - Fresenius Kabi announced today that the US FDA has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra ...
Posted by Michael Wonder on 05 Mar 2024
Sandoz receives FDA approval for first and only denosumab biosimilars
5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...
Posted by Michael Wonder on 26 Feb 2024
Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira
23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
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 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 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 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 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 08 Nov 2023
Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira
7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...
Posted by Michael Wonder on 02 Nov 2023
HHS Secretary Becerra's statement on the FDA’s approval of Wezlana
31 October 2023 - Today, US Department of Health and Human Services Secretary Xavier Becerra released the following statement regarding ...
Posted by Michael Wonder on 31 Oct 2023
FDA approves interchangeable biosimilar for multiple inflammatory diseases
31 October 2023 - Today, the US FDA approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) ...