Celltrion the latest to launch biosimilar of AbbVie's Humira drug in the U.S.

Celltrion USA have announced the launch of Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira (adalimumab) biosimilar, providing an alternative, cheaper, option for patients in a market dominated by Abbvie's Humira. 

Yuflyma is indicated for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

First approved by the Food and Drug Administration on May 23, 2023, Yuflyma became commercially available among key distributors across the U.S. on July 2nd. Yuflyma is listed at $6,576.50 per month. Yuflyma is available in two device types — auto-injector and pre-filled syringe options. More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation. Yuflyma is a citrate-free formulation that is highly concentrated at 100mg/mL. It also maintains stability at 25℃ (77°F) for 30 days to provide longer shelf life than Humira and is administered via a latex-free device.

“The launch of Yuflyma is a critical milestone not only for Celltrion USA, but for patients, healthcare providers, and payers,” said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. “We are committed to providing a patient-centric approach with a focus on increased access to innovative, high-quality biologics in the United States. Celltrion has a demonstrated track record of commercial, regulatory and manufacturing success globally – including the first monoclonal antibody biosimilar infliximab– and our dedicated immunology commercial team is ready to leverage their experience and market knowledge in the U.S.”

Professor Jonathan Kay of UMass Chan Medical School, said: “The launch of Yuflyma provides patients with one of only a few FDA-approved adalimumab biosimilars that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment.”

Until recently, as reported by Reuters, Abbvie's sales of Humira were the largest of any non-covid prescription drug hitting a eye-watering $21.2 billion in sales for 2022. Yet, Celltrion's development Yuflyma is likely to disrupt Abbvie's sales numbers, with projections suggesting a 37% drop in total sales in 2023 - in large part due to increased competition in this space. 

Celltrion is seeking an interchangeability designation from the U.S. FDA for Yuflyma, tentatively expected Q4 in 2024.