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RSS FeedPosted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
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 07 Nov 2022
MHRA updates biosimilar guidance to allow interchangeability between products
7 November 2022 - The UK’s MHRA has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if ...
Posted by Michael Wonder on 24 Oct 2022
Saskatchewan becomes sixth Canadian province to implement a biosimilar switching policy
21 October 2022 - Saskatchewan joined five provinces and one territory in implementing a biosimilar switching policy, allowing for reference ...
Posted by Michael Wonder on 13 Oct 2022
Amgen's annual trends report finds competition created by biosimilars contributed $21 billion in US health care system savings
12 October 2022 - Ninth Edition of Amgen's Biosimilar Trends Report Examines the U.S. and Global Marketplace with Biosimilars. ...
Posted by Michael Wonder on 12 Oct 2022
Medical industry advocates urge Ontario to offer cheaper versions of prescription medications
11 October 2022 - Medical industry advocates are urging the Ontario government to offer cheaper versions of certain prescription medications ...
Posted by Michael Wonder on 30 Sep 2022
Biogen announced EMA filing acceptance of BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab)
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...
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 19 Sep 2022
Biosimilar medicines can be interchanged
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
Posted by Michael Wonder on 16 Sep 2022
Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
Posted by Michael Wonder on 14 Sep 2022
Lupin receives Health Canada approval for Rymti (biosimilar etanercept)
13 September 2022 - Rymti is Lupin’s biosimilar etanercept approved for all indications of the reference product. ...
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. ...
Posted by Michael Wonder on 30 Aug 2022
Outlook Therapeutics re-submits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
30 August 2022 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 29 Aug 2022
European Commission approves Ranivisio (ranibizumab), a biosimilar to Lucentis
29 August 2022 - Formycon, Polpharma Biologics and Bioeq jointly announce that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 22 Aug 2022
Three imperatives for R&D in biosimilars
19 August 2022 - The biosimilars market is poised to grow over the next decade. ...