The U.S. Food and Drug Administration (FDA) has designated Fresenius Kabi and Formycon AG’s Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara (ustekinumab).
Otulfi is indicated for the treatment of moderate to severe plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy; active psoriatic arthritis in adults and pediatric patients six years or older; and moderately to severely active Crohn’s disease and ulcerative colitis in adult patients.
Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider.
Not all biosimilars receive interchangeability status.
According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria.
