Merry Christie is Director (CMC), Head of Expertise (Biosimilars) at Voisin Consulting Life Sciences (VCLS). She is a regulatory science professional and chemist with 14 years combined experience reviewing CMC/product quality data and performs research to develop and advance pharmaceutical drug development. She has a strong working knowledge of US regulations and cGMP requirements, and experience with original and biosimilar BLAs, INDs, NDAs in all phases of development.
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…