In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. 

Sarah and Dr. Woollett also discuss Samsung Bioepis’ first US Biosimilar Market Report (linked below) and some of its key findings on biosimilar cost savings, uptake and market share. She also shares the way forward to help biosimilars see broader use both in the US and Europe.

Read about the publications mentioned in this episode here:

Samsung Bioepis’ First US Biosimilar Market Report

A 'Global Reference' Comparator for Biosimilar Development

An Efficient Development Paradigm for Biosimilars

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One

The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question

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