WHAT: Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance
WHERE: The New York Academy of Sciences
WHEN: March 9, 2012, 9:00 AM - 5:30 PM
The U.S. Food and Drug Administration (FDA) is currently working toward implementing the Biologics Price Competition and Innovation Act (BPCI) of 2009, which establishes an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" to or "interchangeable" with a drug regulated under the Public Health Service Act. The yet-to-be finalized pathway raises questions that are far more complicated than those posed by traditional, small molecule generics including what type of pre-clinical/clinical data, safety, purity, immunogenicity and potency testing will be required by the FDA in the marketing application. Additionally, while current regulations do not make scientific distinctions between small-molecule drugs and non-biological complex drugs (NBCDs), NBCDs present many of the same scientific challenges to reproduce as biologics, and future regulations will likely be guided by lessons learned from the development of policy for biosimilars in the U.S. and abroad.
This international, scientific conference will focus on considerations for the NBCD regulatory approval pathway given the established guidelines for biosimilars. Plenary sessions will address the most recent regulatory developments, experimental design, interchangeability and immunogenicity issues for follow-on versions of complex drugs from the perspective of key audiences, including industry, regulatory agencies, physicians, and consumers.
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