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RSS FeedPosted 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). ...
Posted by Michael Wonder on 01 Oct 2023
FDA approves Biogen’s Tofidence (tocilizumab-bavi), a biosimilar referencing Actemra
29 September 2023 - Tofidence (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the US. ...
Posted by Michael Wonder on 25 Sep 2023
FDA issues complete response letter for Udencya Onbody biologics license application solely due to an on-going review of inspection findings at a third-party filler
25 September 2023 - No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or ...
Posted by Michael Wonder on 21 Sep 2023
Alvotech provides US regulatory update on AVT02, a high concentration interchangeable biosimilar candidate to Humira (adalimumab)
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...
Posted by Michael Wonder on 30 Aug 2023
Outlook Therapeutics provides regulatory update on FDA review of ONS-5010 / Lytenava (bevacizumab-vikg) for the treatment of wet AMD
30 August 2023 - FDA issues complete response letter for ONS-5010 biologics license application based on CMC and need for further ...
Posted by Michael Wonder on 24 Aug 2023
FDA approves first biosimilar to treat multiple sclerosis
24 August 2023 - The US FDA today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment ...