Viatris launches Hulio (adalimumab biosimilar) in Canada

18 February 2021 - Viatris announced today that Health Canada has approved Hulio, and product is now available in Canada. ...

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Coherus BLA filing for adalimumab biosimilar candidate accepted by FDA for review

17 February 2021 - Coherus BioSciences announced that the United States FDA has accepted for review the 351(k) biologics license application ...

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Fresenius Kabi Canada launches Idacio (adalimumab injection) a biosimilar to Humira (adalimumab) for the treatment of multiple chronic inflammatory conditions

18 February 2021 - Biosimilars offer patients access to affordable, meaningful medicines ...

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Sandoz Canada completes its fifth biosimilar launch with new biosimilar Hyrimoz (adalimumab)

16 February 2021 - Hyrimoz for use in nine indications covered by the reference medicine in the fields of rheumatology, gastro-enterology ...

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Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)

15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...

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Biosimilars: is interchangeability the proof of the pudding?

15 February 2021 - While apparently non‐inferior to originator biologics, other factors need to be considered before switching ...

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Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis

1 February 2021 - This novel formulation provides an alternative administration option for Canadian physicians and their patients. ...

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Bio-Thera Solutions announces FDA accepts biologics license application for BAT1706, a proposed biosimilar to Avastin

28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...

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Adalimumab biosimilars face product obsolescence before launch

 6 January 2021 - Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet ...

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Pandemic delays FDA decision on Biocon's bevacizumab application

27 December 2020 - For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its ...

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Sandoz Canada receives authorisation from Health Canada to launch new biosimilar Hyrimoz (adalimumab)

17 December 2020 - Hyrimoz approved for use in all same indications as reference medicine* including rheumatology, gastro-enterology and dermatology. ...

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FDA approves Amgen's Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab)

17 December 2020 - Fifth FDA Approval From Amgen's Biosimilars Portfolio. ...

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In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition

10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...

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Valeo Pharma announces Health Canada approval for Redesca and Redesca Hp

9 December 2020 - Valeo Pharma announced today that Health Canada has issued a Notice of Compliance for Redesca and ...

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Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency

25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...

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