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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Regulatory Environment for Follow-on Biologics


    Follow-on protein products (US) or similar biological medicinal products (biosimilars) (EU) have emerged as a topic of great interest, leading to discussions on the regulatory, scientific, political and legal implications of approving and marketing these products. The concept of follow-on versions of biopharmaceuticals has gained ground with the February 2006 EMEA and May 2006 FDA approvals of Sandoz GmbH’s Omnitrope® and the April 2006 EMEA approval of BioPartner GmbH’s Valtropin®. With these approvals, the ensuing debates have now moved from one of what is required for approval of follow-ons to what is the appropriate regulatory guidance (e.g. nomenclature, pharmacy dispensing) now that these products are on the market. This chapter will summarize the current regulatory landscape for follow-on protein products/biosimilars in the US and EU as well as the scientific considerations.

    About the Authors

    James W. Precup, Ph.D., Regulatory Scientist, Indianapolis Site Regulatory Affairs, Eli Lilly and Company
    Dr. Precup has seven years post-approval regulatory experience with biologic products (human coagulation factors/plasma proteins), and biotechnology - E.coli derived drug substances. Prior to his assignments in regulatory affairs, Dr. Precup was Manager of Technical Operations responsible for production support and process improvement of plasma derived coagulation factors. Dr. Precup received a B.S. and M.S. degrees in Biology from the University of Illinois, Urbana, and a Ph.D. degree in Microbiology/ Molecular Biology from Southern Illinois University.

    Renee D. Schantz-Shirley, Associate Regulatory Consultant, Regulatory Affairs Chemistry, Manufacturing, and Control, Eli Lilly and Company.
    Ms. Schantz-Shirley has over 15 years of experience in CMC Regulatory Affairs, with responsibilities covering early and late stage development and post-approval regulatory support during this time. Most recently, Ms. Schantz-Shirley is responsible for coordination of CMC Regulatory Intelligence and Influence activities within the CMC Regulatory Affairs organization. Current responsibilities also include development and maintenance of tools to provide cross-product technical and regulatory support for development projects. Prior to her assignment in regulatory affairs, Ms. Schantz-Shirley was an Organic Chemist in Chemical Process Research and Development (1985-1991). Ms. Schantz-Shirley received a B.S. degree in Chemistry and Biology from Purdue University, West Lafayette, IN in 1985.

    Josephine Secnik, M.S., MBA, Regulatory Scientist, Indianapolis Site Regulatory Affairs, Eli Lilly and Company
    Ms. Secnik is has 4 years of experience in CMC Regulatory Affairs, with responsibilities for pre- and post-approval CMC regulatory submissions. Prior to her assignment in Regulatory Affairs, Ms. Secnik was a Quality Assurance Consultant with responsibilities for early and late stage biopharmaceutical development projects (1998-2002). Ms. Secnik was previously Senior Financial Analyst for Bioproducts (1995-1997) and Senior Associate Biochemist with responsibilities for purification process development and pilot-scale manufacturing of clinical trial material (1990-1995). Ms. Secnik received a B.A. and M.S. degree in Biochemistry from Case Western Reserve University, Cleveland, OH in 1987 and 1990 and an MBA degree in Finance from Indiana University, Bloomington, IN in 1995.

    John Towns, Director, Global Regulatory Affairs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
    Dr. John Towns is Director, Global CMC Regulatory Affairs at Eli Lilly and Company. Dr. Towns has both pre-approval and post-approval global CMC regulatory affairs responsibilities for Lilly’s portfolio of chemically synthesized and biotechnology-derived drug substances and drug products, including the regulatory activities at the 15 manufacturing sites around the world. Prior to his assignment in regulatory affairs, Dr. Towns was Head of Biopharmaceutical Technology Development with responsibilities for early and late stage biopharmaceutical development projects (1994-1999). Dr. Towns was previously Senior Analytical Chemist with responsibilities for line extension development and product technology advancement for recombinant protein products (1991-1994). Dr. Towns received a BS degree in Chemistry from California Polytechnic State University, San Luis Obispo, California in 1986 and a Ph.D. degree in Analytical Chemistry from Purdue University, West Lafayette, Indiana in 1991.

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