What You Must Know About FDA’s New Biosimilars Guidance | Siegel | Sept. 27, 2012, 2 PM EDT

What You Must Know About FDA’s New Biosimilars Guidance | Siegel | Sept. 27, 2012, 2 PM EDT

March 14th, 2012 // 12:46 pm @

On February 9, FDA released its first guidance on potential approval pathways for BLAed biosimilar drug products.

A variety of positive options for strategic and tactical approaches were detailed. This included the use of both US- and ex-US- innovator data to partially support these products and the possibility of extrapolating extant data to allow consideration of all approved indications of a branded product for a biosimilar product

However, many questions remain for practical implementation of the Act.

Some of these outstanding questions include:

  • The lack of mechanisms presently in place to support and allow for true interchangeability of biosimilars for innovator products
  • The actual data burden that will need to be submitted for key classes of biosimilar “generic” products
  • Detailed determinations of exclusivity for the first biosimilar products against the innovator product
  • The realistic timeframes for action on submitted applications for such products.

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Join our Webinar Sept. 27, 2 PM EDT, with Dr. Evan Siegel, and learn the answers to the above questions as well as:

  • Basic tenets of the new law, related to biosimilar drug products;
  • General requirements of biosimilar (351(k)) applications;
  • FDA’s likely approaches to review of biosimilar and potentially interchangeable product applications;
  • Previous precedents and ongoing reviews of biologic drugs and concordance or disconnects with the new law and guidances;
  • Suggestions on how to deal with the FDA in the biosimilars arena; and
  • Key considerations in determining the desirability of developing such products based on the guidances and previous actions of the Agency.

About Your Speaker:

President and CEO Dr. Evan Siegel, Ph.D., founded GZP in 1999 from his consulting firm, Ground Zero Strategics, Ltd. He served as Consultant and then Chief Executive Officer of OXO Chemie Inc. from 1997 to 1999. Before he joined OXO Chemie, he was the Vice President, Regulatory Affairs and Bioethics for Medical Science Systems, Inc., now Interleukin Genetics. Prior to that he was Director of Regulatory Consulting Services and Principal Regulatory Scientist for Quintiles, Inc., in Research Triangle Park, North Carolina. Dr. Siegel has held positions as a Toxicology Reviewer at the US Food and Drug Administration and Food and Drug Branch, California Department of Health Services and, at the latter, was Supervising Toxicologist and Chief of Special Services. He has served in regulatory affairs and executive positions in both the pharmaceutical industry (Astra, Syntex, Medical Science Systems and OXO Chemie) and trade association environments. He attended the Waksman Institute of Microbiology where he earned both his Master and Doctor of Philosophy degrees in Virology and Molecular Biology. He is an Adjunct Professor in the Centre for Integrated Preclinical Drug Development, University of Queensland, Australia.

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