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Session 1505: REGULATORY, SCIENTIFIC, AND CONSIDERATIONS OF BIOSIMILAR DEVELOPMENT (PART I)
Session Chair(s)
Ning Li, MD, PhD
Vice President, Head of Asia Regulatory and Medical Policy
Sanofi, China
The recent passage of law and publication of guidance in US provides a more defined pathway, as EU regulatory agencies did, for the development of biosimilar products by the pharmaceutical industry. However, unlike generic drugs of small molecules, the regulatory, scientific, and legal issues still present significant challenges due to the unique characteristics of individual biological products. This workshop will discuss the following: An update on the law and guidance for biosimilars and the newly approved products; The regulatory process for approval of biosimilars in US; The legal challenges pertaining to biosimilar products; The concept of comparability and the technical challenges related to biosimilar product development; and Immunogenicity as an important issue for biosimilars.
Speaker(s)
Opening Remarks
Ning Li, MD, PhD
Sanofi, China
Vice President, Head of Asia Regulatory and Medical Policy
Update on the Biosimilar Regulatory Pathway
Duu-Gong Wu, DrSc, PhD
PPD, United States
Senior Director, Global Regulatory Affairs
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