Biosimilars and Generics: Key Regulatory Strategies for Lower-Cost Products

Biosimilars and Generics: An Overview

Biosimilars and generics play a crucial role in enhancing access to medicine by lowering costs. A recent webinar featured experts from IQVIA discussing regulatory strategies that facilitate market approval.

Regulatory Framework for Generics

Keith McDonald, senior director of regulatory affairs, provided insights into the Hatch-Waxman Act of 1984, which laid the foundation for generic drugs in the US. He emphasized the significance of bioequivalence for drug approval and outlined essential components necessary for regulatory submissions.

Insights on Biosimilar Development

Transitioning to biosimilars, McDonald discussed various regulatory pathways utilized in the US and EU, referencing the Biologics Price Competition and Innovation Act of 2010. He highlighted ongoing efforts to build confidence in biosimilar use amid common skepticism.

Addressing UK Specifics Post-Brexit

With the UK's evolving regulatory identity post-Brexit, McDonald described the emphasis on analytical characterization over comparative efficacy studies for approval. He also raised the prospect of parallel approvals to streamline market entry.

Expanding into Emerging Markets

Ankit Tyagi, associate director of regulatory affairs, reiterated the opportunities and challenges in emerging markets. He detailed various approval pathways and stressed the importance of local compliance, including adherence to Good Manufacturing Practices.

The webinar underscores the necessity of a robust regulatory strategy for both biosimilars and generics to successfully enhance patient access to affordable treatments.