Celltrion Receives EC’s Approval for Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases

February 16, 2021 Auto Bot approval, Biosimilars, Celltrion, EC, receives, Treatment 0

Shots:

  • The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases
  • The approval is based on analytical, pre/ clinical studies, demonstrating that Yuflyma is comparable to the reference product, in terms of safety, efficacy, PK/PD, and immunogenicity up to 24wks. and 1yr following treatment
  • The company will take ECDRP to minimize lead time to launch the product in the UK and remains committed to delivering innovative and affordable medications

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Fortune

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