Recent Adalimumab Biosimilar Updates

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On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®.  Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according to Celltrion, may cause less pain upon injection than other adalimumab biosimilars.  The European Commission’s marketing authorization is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway.

On February 16, 2021, Sandoz Canada, Inc. announced the launch of Hyrimoz®, its adalimumab biosimilar, in Canada.  Hyrimoz® is a biologic therapy approved to treat nine of the twelve serious rheumatological, gastroenterological, and dermatological conditions in adults and children covered by Humira®.  Hyrimoz® joins a list of four Sandoz biosimilars that have been authorized in Canada in the past year.

On February 17, 2021, Coherus BioSciences, Inc. announced that its 351(k) Biologics License Application for CHS-1420, its adalimumab biosimilar, has been accepted for review by the U.S. Food and Drug Administration.  The FDA set a Biosimilar User Fee Act action date for December 2021, and if approved, Coherus could launch its adalimumab biosimilar on or after July 1, 2023, per its prior agreement with AbbVie, the manufacturer of Humira®.

On February 18, 2021, Fresenius Kabi Canada announced the launch of IDACIO®, its adalimumab biosimilar, in Canada.  IDACIO® is approved for all indications of the reference medicine in the areas of rheumatology, gastroenterology and dermatology.  IDACIO® is the first biosimilar introduced by Fresenius Kabi in North America.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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