Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara (ustekinumab).
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Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi as an interchangeable biosimilar to the reference product Stelara (ustekinumab).
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.
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“Fresenius Kabi is pleased to receive this interchangeable designation for Otulfi, and we will continue to evaluate all possibilities in the development and commercialization of our biosimilar portfolio that help create access for patients and healthcare professionals to important, high-quality and affordable therapies,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board.
According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA).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. This demonstrates that patients who alternated between the reference product and the biosimilar, then returned to the reference product, exhibited no clinically meaningful differences in safety, efficacy, or immunogenicity. This ensures the same clinical outcome for patients treated exclusively with the reference product.
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Source – businesswire
