The Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free biosimilar to Humira® (adalimumab).
Yuflyma is a tumor necrosis factor indicated for:
- Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.
- Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
- Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA; may be used alone or with non-biologic DMARDs.
- Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
- Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.
- Ulcerative colitis (UC): moderately to severely active UC in adult patients.
- Plaque psoriasis: treating adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
- Hidradenitis suppurativa: moderate to severe hidradenitis suppurative in adult patients.
The approval of Yuflyma was based on data demonstrating that the biosimilar and reference product were similar with regard to efficacy, safety, and immunogenicity after 24 weeks and 52 weeks of treatment.
Yuflyma is supplied as 40mg/0.4mL in single-dose prefilled autoinjectors (Yuflyma AI) and single-dose prefilled syringes. The product is expected to be available in July 2023.
The Company is also seeking an interchangeability designation from the FDA, which is expected in the fourth quarter of 2024.
- Celltrion USA announces US FDA approval of Yuflyma® (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira® (adalimumab) biosimilar. News release. Celltrion USA. Accessed May 24, 2023. https://www.businesswire.com/news/home/20230524005407/en/Celltrion-USA-Announces-U.S.-FDA-Approval-of-Yuflyma%C2%AE-adalimumab-aaty-a-High-Concentration-and-Citrate-Free-Formulation-of-Humira%C2%AE-adalimumab-Biosimilar.
- Yuflyma. Package insert. Celltrion USA; 2023. Accessed May 24, 2023. https://www.celltrionhealthcare.com/en-us/products/yuflyma/CT-P17-BLA-USPI.pdf.