Celltrion’s Adalimumab Biosimilar Yuflyma® Receives FDA Approval

In time for its expected July launch, Celltrion USA received the FDA’s go-ahead yesterday to market Yuflyma, a high-concentration form of adalimumab. Its nonproprietary name is adalimumab-aaty. The biosimilar’s approval covers the eight main indications shared by the other approved biosimilars for adalimumab:

  • Ankylosing spondylitis
  • Crohn’s disease (adult and pediatric)
  • Juvenile idiopathic arthritis
  • Hidradenitis suppurativa
  • Plaque psoriasis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Ulcerative colitis

This represents Celltrion’s fifth biosimilar approval in the US, and its second immunology biosimilar (after infliximab). Tom Nusbickel, Chief Commercial Officer at Celltrion USA, stated in a press release, ““As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for U.S. patients.” As Mr. Nusbickel described recently in an interview with BR&R, Celltrion USA will be marketing this agent with its own sales force.

Yuflyma is a citrate-free formulation, and it is the third adalimumab biosimilar available in the high-dose concentration (100 mg/mL), the formulation used by four-fifths of patients taking the reference drug.

Celltrion USA also stated that it is seeking an interchangeability designation for Yuflyma, but that would not be obtained prior to Q4 2024.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.