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RSS FeedPosted 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) ...
Posted by Michael Wonder on 23 Oct 2023
Celltrion USA announces US FDA approval of Zymfentra (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease
22 October 2023 - Zymfentra is the first and only FDA approved subcutaneous formulation of infliximab approved for the maintenance treatment ...
Posted by Michael Wonder on 12 Oct 2023
Alvotech provides update on status of US biologics license application for AVT04
12 October 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 08 Oct 2023
Biocon biologics receives complete response letter from US FDA for biosimilar insulin aspart
7 October 2023 - The US FDA has issued a complete response letter for the biologics license application for insulin aspart. ...
Posted by Michael Wonder on 06 Oct 2023
FDA grants interchangeable designation to Pfizer’s biosimilar Abrilada
5 October 2023 - Interchangeable designation supported by positive data from the REFLECTIONS B538-12 study. ...
Posted by Michael Wonder on 06 Oct 2023
Coherus announces resubmission of biologics license application supplement for Udenyca Onbody
5 October 2023 - Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler. ...
Posted by Michael Wonder on 03 Oct 2023
Adalimumab-adbm, Boehringer Ingelheim’s Interchangeable biosimilar to Humira, now available at low wholesale acquisition cost
2 October 2023 - Adalimumab-adbm will be priced at an 81% discount to Humira (adalimumab). ...