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RSS FeedPosted by Michael Wonder on 22 Mar 2023
Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes
20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...
Posted by Michael Wonder on 02 Mar 2023
FDA and FTC collaborate to advance competition in the biologic marketplace
2 March 2023 - In 2021 alone, the US spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions ...
Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
Posted by Michael Wonder on 16 Feb 2023
Stimufend (pegfilgrastim-fpgk) now available in the United States
16 February 2023 - Fresenius Kabi introduces its first biosimilar in the US. ...
Posted by Michael Wonder on 15 Feb 2023
Henlius announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
14 February 2023 - The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in ...
Posted by Michael Wonder on 06 Feb 2023
Sandoz biologics license application for proposed biosimilar denosumab accepted by US FDA
6 February 2023 - Submission supported by comprehensive analytical and clinical data package. ...
Posted by Michael Wonder on 31 Jan 2023
Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States
31 January 2023 - Four years of real world experience in more than 300,000 patients and over 60 countries. ...
Posted by Michael Wonder on 26 Jan 2023
A “method of use” to prevent generic and biosimilar market entry
25 January 2023 - A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny ...
Posted by Michael Wonder on 24 Dec 2022
Celltrion USA announces submission of the biologics license application of novel subcutaneous formulation of CT-P13 to US FDA
22 December 2022 - CT-P13 SC is a novel subcutaneous formulation of infliximab. ...
Posted by Michael Wonder on 22 Dec 2022
Update on US regulatory status of AVT02, Alvotech’s proposed high concentration, interchangeable biosimilar to Humira
22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for ...
Posted by Michael Wonder on 15 Dec 2022
Fresenius Kabi receives US FDA approval for biosimilar Idacio (adalimumab)
14 February 2022 - Idacio is a citrate free formulation of adalimumab. ...
Posted by Michael Wonder on 10 Dec 2022
FDA accepts Biogen biologics license application for BIIB800, a biosimilar candidate referencing Actemra (tocilizumab)
9 December 2022 - Biogen announced that the US FDA has accepted for review the abbreviated biologics license application for ...
Posted by Michael Wonder on 23 Nov 2022
Rezvoglar becomes second interchangeable insulin biosimilar
23 November 2022 - The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it ...
Posted by Michael Wonder on 28 Sep 2022
Celltrion USA receives US FDA approval for its oncology biosimilar Vegzelma (bevacizumab-adcd) for the treatment of six types of cancer
28 September 2022 - The approval is based on totality of evidence with no clinically meaningful differences in efficacy or safety ...
Posted by Michael Wonder on 06 Sep 2022
Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend (pegfilgrastim-fpgk)
6 September 2022 - Fresenius Kabi’s first approved U.S. biosimilar. ...