To Be Or Not To Be Interchangeable: Global Biosimilar Development

New article on Life Science Leader. Antonina Nikolova, PhD, Principal Regulatory Consultant, Kymanox Corporation, discusses the biosimilar landscape and how it continues to evolve, amid a harmonized global approach to interchangeability.

Biosimilars have emerged as a gamechanger, offering more affordable treatment options for complex biological therapies. But one key question remains: Should developers prioritize pursuing the “interchangeable” biosimilar designation to allow substitution at the pharmacy level? Or focus efforts on the standard biosimilar approval pathway to maximize broad accessibility?

In an insightful analysis, Antonina Nikolova explores the complex global landscape around biosimilar interchangeability. She highlights the lack of harmonized regulations, with divergent requirements across regions like the costly additional switching studies mandated in the U.S.

Read on Life Science Leader

About the Author:

Dr. Antonina Nikolova is a seasoned former FDA expert with direct experience in the most influential pharmaceutical regulatory agencies in the world. Dr. Nikolova is currently a consultant at Kymanox. During her 13+ years of experience at FDA, she was actively involved in review of biologics applications and ensuring regulatory requirements were met throughout the product life cycle, including Investigational New Drug (IND) applications, Biologics Licensing Applications (BLA), and Postmarketing and Postmarketing Supplements (PAS, CBE-30, CBE) for Biosimilars.

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