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Biography

Hazel Gorham, PhD, Director, Biosimilars Development, Scientific Affairs, has 26 years of experience in both academic and pharmaceutical research/industry across a wide range of roles including developing Clinical Development Plans for biosimilars. Dr. Gorham has experience in all aspects of biosimilar development including study design and regulatory agency discussions. She has experience in all aspects of clinical trial project management and has managed the conduct of multiple Phase I through IV clinical trials and post-marketing studies across geographical regions and differing therapeutic areas. Dr Gorham completed her post-doctoral graduate studies in microbiology at the University of Warwick, UK.

Abstract

The market of biologics is growing at nearly twice the rate of pharma as a whole. The expiration of patents and other intellectual property rights for originator biologicals over the next decade opens up opportunities for biosimilars to enter the market and increase industry competition. In order to be cost effective a biosimilar product needs access to global markets based on a single development programme that meets the requirement of regulators internationally. Despite increasing alignment in the regulatory requirements for biosimilars between EMA, FDA, WHO and other jurisdiction, there are still many scientific and practical challenges for demonstrating biosimilarity and interchangeability including scientific factors, drug interchangeability and statistical considerations.

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