Celltrion, Inc. announced that the US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty), as an interchangeable biosimilar to Humira (adalimumab). Yuflyma is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira biosimilar, approved for multiple inflammatory indications.
""With this new designation, Yuflyma is further positioned to help more patients gain access to and afford the therapy they need,"" said Thomas Nusbickel, chief commercial officer at Celltrion USA. "" Yuflyma has the same dosage form, route of administration, and dosing regimen as the reference product. The pharmacist's ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab.""
The interchangeable designation was supported by data from the phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and Yuflyma during the dosing interval of Week 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV) 2024.
FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws.
The high-concentration form of Yuflyma was FDA-approved in May 2023 and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. Yuflyma was introduced into the US commercial market on July 2, 2023.
Yuflyma is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost (WAC) list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system. The branded version is priced at a 5% discount to the current WAC of Humira (adalimumab).
Yuflyma is the world's first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. Yuflyma is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Yuflyma has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe. Yuflyma is a recombinant fully human anti–tumour necrosis factor a (anti-TNFa) monoclonal antibody. Yuflyma is available in 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL.
Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide.