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CMC considerations for US biosimilars development

Post thumbnail CMC considerations for US biosimilars development

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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    publication by

    Alexandra Beumer Sassi
    Alexandra Beumer Sassi, PhD, RAC
    Senior Director, CMC
    As a Director, Chemistry, Manufacturing, and Controls (CMC) at VCLS, Alexandra (Alex) is responsible for providing CMC and regulatory consulting services to clients to help them take their…
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    Valérie Pimpaneau thumbnail
    Valérie Pimpaneau
    Vice President CMC
    As Vice President at VCLS, Valerie is responsible for leading the CMC Group in the design and optimization of CMC strategies adapted to the stage of product development and aligned with the relevant regulatory requirements and innovative pathways. This service covers conventional small molecules, biologics and gene and cell therapy products and includes the provision of advice on all regulatory and technical aspects of biotechnology product development.
    Merry Christie thumbnail
    Merry Christie
    Associate Director CMC
    Merry has more than 14 years of combined experience gained working in the US regulatory arena, together with a history of CMC technical experience with all aspects of the manufacturing and development of biologicals. Her technical expertise includes analytical method development and validation, formulation development, quality control, manufacturing changes, comparability studies and stability studies. Merry worked in the Office of Biotechnology Products in the Office of Product Quality at FDA, where she was responsible for a variety of biotechnology products in all stages of their lifecycle, from early development to post-approval. In addition, Merry has experience with products granted under Priority Review and with Orphan Drug designations.