The US Food and Drug Administration (FDA) has approved expanded indications for adalimumab-aaty (Humira) biosimilar Yuflyma (Celltrion) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescents aged 12 and older, and uveitis (UV) in pediatric patients aged 2 and up.
The FDA previously approved Yuflyma as a biosimilar to Humira for a variety of indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps). HS and UV were previously approved in adult patients, and the latest approval expands these two indications to include pediatric and adolescent populations.
“Adolescent HS and pediatric UV are chronic inflammatory conditions that can have serious sequelae and place a significant burden on patients, their families, and caregivers. It impacts patients physically and also emotionally and socially,” says Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, in a news release. “With this label expansion, Yuflyma is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians.”
Yuflyma was first introduced in the US market in July 2023 and is currently available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution for injection in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions with two pricing options.
