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Newly released FDA draft guidelines for biosimilar drugs to be discussed at conference

On March 9, the New York Academy of Sciences will present "Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance." This full-day conference will explore current definitions, global scientific and regulatory hurdles, and future challenges for follow-on versions of complex drugs.

On February 9, 2012, the FDA released its much-anticipated new draft guidelines for implementing the Biologics Price Competition and Innovation Act of 2009, which called for an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" to, or "interchangeable" with, a previously approved and regulated drug. However, current U.S. regulations do not make scientific distinctions between small-molecule drugs and non-biological complex drugs; although the latter may present many of the same scientific and clinical challenges to reproduce as biologics.

In light of the recently drafted approval guidelines for biosimilars in the U.S., and increased international concern for new follow-on biological and non-biological products currently defined as "interchangeable" in both established and emerging markets abroad, the Academy will bring together experts representing a variety of perspectives, including industry, regulatory agencies, physicians, and consumers. Representation from the FDA will provide an overview of the demonstration of therapeutic equivalence of complex drug products, which shall inform the day's broader discussions about the regulation of non-biological complex drugs.

Plenary sessions will address the most recent regulatory developments and experimental design, interchangeability, and immunogenicity issues for follow-on versions of complex drugs; featuring conversations led by Larry Lee, PhD, FDA; Ivana Knezevic, MD, PhD, World Health Organization; Huub Schellekens, MD, PhD, Utrecht University; Janet S. Wyatt, PhD, RN, FAANP, Institute of Pediatric Nursing and Arthritis Foundation; Jan Mueller-Berghaus, MD, Paul-Ehrlich-Institut; Beatriz Silva-Lima, PharmD, PhD, University of Lisbon; Chris Holloway, PhD, ERA Consulting Group; and Andrew D. Zelenetz, MD, PhD, Memorial Sloan-Kettering Cancer Center.

An international audience of basic researchers, policy makers, and regulatory and public health experts from academia, industry, government, and NGOs will participate in the conversation about the changing regulatory landscape for biological and non-biological complex drugs. The open format of the meeting, including multiple question and answer periods and a working lunch brainstorming session culminating in a full-meeting discussion, will foster dialogue between disparate groups that may aid in defining and determining the criteria for follow-on complex drugs and help move U.S. policy forward.

Contact: Melinda Miller
New York Academy of Sciences

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