The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products. This pathway brought the hope of lower cost biologics, perhaps similar to what was accomplished by generics for small molecule drugs. Twelve years have now passed since the BPCI Act and experience continues to be gained with biosimilars development. With this experience comes the knowledge of the essential CMC-related considerations for development that may be overlooked by those who are new to this product type. This paper discusses: the importance of Chemistry, Manufacturing and Controls (CMC) data in the biosimilar application; what is meant by an ‘abbreviated’ licensure pathway; the role of the reference product; the preparation for biosimilar inspections; and how careful timing of manufacturing changes can lead to faster approval without sacrifi cing process optimisation.
Published on: Apr 26, 2022
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