FDA Grants Approval for Stelara® Biosimilar FYB202/OtulfiTM

Formycon AG has announced that the U.S. Food and Drug Administration (FDA) approved FYB202/OtulfiTM, a biosimilar to Stelara®. This approval covers treatment for Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis, and active psoriatic arthritis.

The approval is based on a comprehensive data package that includes analytical, pre-clinical, clinical, and manufacturing data. FYB202/OtulfiTM has shown comparable efficacy, safety, and pharmacokinetics to the reference drug Stelara® in patients with moderate to severe plaque psoriasis.

FYB202/OtulfiTM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries, while Stelara® is a registered trademark of Johnson & Johnson.