Celltrion USA Launches 80 mg Dose of Adalimumab Biosimilar, Yuflyma

Celltrion USA recently announced the launch of an 80 mg dose of Yuflyma (adalimumab-aaty), its high-concentration and citrate-free formulation biosimilar to Humira (adalimumab; AbbVie). Yuflyma was first available as a single 40 mg dose in a prefilled syringe with a safety guard and as an autoinjector.¹

The 80 mg Yuflyma dose will be offered at the same price as the 40 mg dose to meet the needs of patients, prescribers, and payers, according to Celltrion. Additionally, a 20 mg dose is expected to be available in pharmacies later in quarter 1 of 2024.

According to the announcement, more than 80% of patients treated with adalimumab in the US rely on a high-concentration and citrate-free formulation. Yuflyma is highly concentrated at 100mg/mL and maintains stability at 25℃ (77°F) for 31 days, with protection from light, and is a latex-free device.

“Yuflyma demonstrated a comparable efficacy, safety, pharmacokinetics, and immunogenicity profile as the reference product. These new dose amounts and the auto-injector option provide flexible regimens. These new dose amounts and the 2-step auto-injector option provide flexibility and convenient self-administration,” said Thomas Nusbickel, chief commercial officer at Celltrion USA, in the news release.

To assist both patients and health care providers when using Yuflyma, Celltrion offers the Celltrion CONNECT Patient Support Program along with the Celltrion CARE Co-pay Assistance Program.

Yuflyma was the 9th FDA-approved adalimumab biosimilar available to US patients in May 2023. Yuflyma is approved to treat 8 inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Celltrion has also applied for interchangeability designation from the FDA for Yuflyma, and a decision is expected in Q4 of 2024.²

Yuflyma is hoping to join Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as an autoinjector adalimumab biosimilar with interchangeability designation. Cyltezo received interchangeability designation in October of 2021.²

References

1. Celltrion USA announces launch of additional doses of Yuflyma (adalimumab-aaty) in the US. News release. Celltrion USA. January 17, 2024. Accessed January 19, 2024. https://www.celltrion.com/en-us/company/media-center
2. Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. News release. Celltrion Healthcare. May 24, 2023. Accessed May 25, 2023. https://www.celltrionhealthcare.com/board/en_newslist/102