FDA New Guidelines for Biosimilars and Biobetters:  An Outlook for 2013

January 16, 2013 |Archive Now Available


The development of biosimilars have garnered great interest for their cost-effective benefits in patient care as well as developmental opportunities for industry sponsors who see a new revenue stream. However, the pathway to commercialization is complicated by regulatory challenges. There is still a need to understand the expected requirements for biosimilars registration, as well as focused data requirements to establish a viable, safe and effective product.


The goal of this presentation is to provide an understanding of the current regulations and continued challenges, future directions by the regulatory authorities and provide insight into the regulatory pathway for biosimilar and biobetter registration.



Webinar Speaker:

Dr. Steven Engel, MS, PharmD, Senior Principal Scientist, Worldwide Regulatory Affairs, Merck & Co., Inc.

Steven I. Engel is currently Senior Principal Scientist in Worldwide Regulatory Affairs for Merck & Co., Inc.  He is also Principal Consultant for Drug Development and Regulatory Strategies, LLC . Dr. Engel  brings an established track record of drug and biologic development expertise to the industry for the last 25 years. He has held increasingly more senior positions of responsibility for global regulatory strategy, registrations and quality compliance functions in companies such as Cyanamid, Abbott Laboratories, Otsuka, Baxter Healthcare, Cubist, Vertex and Par Pharmaceuticals, acting as Vice President of Regulatory Affairs in the last four. He has a proven track record of development and implementation of global regulatory strategies leading to multiple drug and biologic product registrations across several therapeutic areas in major, minor and emerging markets.  Dr. Engel earned bachelor degrees in biology and pharmacy fromDrakeUniversity, a Master’s degree in pharmacology from theUniversityofNorth Carolinain Chapel Hill and a PharmD degree while on faculty at theUniversityofFlorida.

Date: Archive Now Available

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