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.