Pfizer supplemental application for ABRILADA interchangeability accepted by USFDA for review

A biosimilar with an interchangeable designation can be substituted for the reference product by a pharmacist, subject to individual state laws. An interchangeable designation is granted by the FDA to biosimilars that meet regulatory requirements, beyond the standards required to establish biosimilarity, to demonstrate that the product is expected to produce the same clinical result as the reference product in any given patient. To achieve an interchangeable designation, the manufacturer must also demonstrate that there is no additional risk or reduced efficacy if a patient switches back and forth between an interchangeable product and a reference product, compared to a reference product without switching.

Biosimilars play an important role in the treatment of autoimmune conditions. They have the ability to help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care. 

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