The BioCentury Show Ep. 89 - Delivering on the biosimilars promise, a conversation with Gillian Woollett
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Jul 10, 2025 Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, shares her expertise on biosimilars regulation. She argues that streamlining FDA processes could cut development time and costs significantly. Woollett highlights the commercial challenges in the U.S., particularly the impact of pricing policies on investment in biosimilars. She also addresses the complexities of interchangeability and emphasizes the need for improved incentives to bolster market entry and competition for biosimilars.
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Cut Biosimilar Development Time
- Eliminating unnecessary clinical trials can halve biosimilar development time and cost.
- Advanced analytics provide strong evidence without requiring comparative efficacy studies.
Analytics Surpass Clinical Trials
- Advanced analytical and functional assays surpass clinical studies in assessing biosimilar equivalence.
- Clinical trials often lack sensitivity and add no new regulatory value, making them ethically questionable.
Push for Global Reference Product
- Advocate for a single global reference product to streamline biosimilar approval worldwide.
- Align legal and scientific frameworks to enable global biosimilar development and reduce duplication.