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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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Biosimilar medicines can be interchanged

19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...

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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 ...

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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. ...

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Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend (pegfilgrastim-fpgk)

6 September 2022 - Fresenius Kabi’s first approved U.S. biosimilar. ...

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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 ...

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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 ...

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Three imperatives for R&D in biosimilars

19 August 2022 - The biosimilars market is poised to grow over the next decade.  ...

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