Barriers to US biosimilar market growth: lessons from biosimilar patent litigation

6 August 2021 - High biologic drug prices have placed substantial strain on the US health care system.  ...

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Competition from biosimilars drives price reductions for biologics in the French single payer health system

6 August 2021 - France has a single payer health insurance system that has the authority to impose pharmaceutical price reductions ...

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Formycon and Bioeq announce submission of the biologics license application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. FDA

5 August 2021 - Formycon and its license partner Bioeq announce that the biologics license application for FYB201, Formycon’s biosimilar ...

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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

28 July 2021 - Availability of insulin products will help increase access and potentially lower the cost of insulin for people ...

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J&J and Pfizer quietly resolve Remicade biosimilar lawsuit

27 July 2021 - In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a ...

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Sorrento announces its partner Mabpharm has received marketing approval in China for infliximab biobetter

20 July 2021 - Sorrento to exclusively market the product outside of China including US, Japan and Europe. ...

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Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA

29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...

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Bevacizumab on the PBS

2 July 2021 - Mvasi, a biosimilar brand of bevacizumab, was listed on the PBS from 1 June 2021, as ...

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Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz

25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...

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US plays catch-up with Europe over biosimilar patents

17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...

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Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab

17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...

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Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application

2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed ...

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Experts expect to see “second wave” of biosimilars approvals

2 June 2021 - Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges ...

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Biosimilar bevacizumab on the PBS - information for health professionals and patients

21 May 2021 - A biosimilar brand of bevacizumab (Mvasi) will be listed on the PBS on 1 June 2021. Information ...

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Quebec announces intention to implement a biosimilar switching policy

18 May 2021 - Biosimilars Canada today congratulated the Government of Quebec and Minister of Health and Social Services Christian ...

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