DIA/FDA Biosimilars Conference Spotlights BsUFA and Scientific and Regulatory Issues

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This conference will explore FDA’s plans to implement BsUFA to review the future path for patients and doctors as potentially interchangeable biologics are coming forth in the market, and classify the challenges associated with demonstrations of biosimilarity.

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Join the conversation on Twitter. Follow #DIABiosimilars and #DrugInfoAssn.

DIA, the premier global association dedicated to knowledge exchange that fosters innovation to raise the level of health and well-being worldwide, will co-host the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA from September 12-13 in Washington, DC.

This conference will explore FDA’s plans to implement BsUFA to review the future path for patients and doctors as potentially interchangeable biologics are coming forth in the market, and classify the challenges associated with demonstrations of biosimilarity.
Featured topics will include:

  •     Stepwise approach to demonstrating biosimilarity
  •     Totality-of-the-evidence approach to be used by FDA to review applications for biosimilar products
  •     Considerations for the analytical similarity assessments when designing a biosimilar development program
  •     Considerations of the complexities of therapeutic protein products when designing a biosimilar development program, including manufacturing process considerations
  •     General scientific principles in conducting comparative structural and functional analyses, animal testing, human PK and PD studies, clinical immunogenicity assessment, and clinical safety and effectiveness studies
  •     Considerations for global biosimilar product development programs
  •     Postmarketing safety monitoring considerations
  •     BsUFA requirements and implementation
  •     Lessons learned from clinical development programs—regulatory and industry perspectives
  •     Path forward—regulatory and industry panelist discussion

Join the conversation on Twitter. Follow #DIABiosimilars and #DrugInfoAssn.

ABOUT DIA
DIA (http://www.diahome.org) is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. Stay updated on hot topic news at #druginfoassn on Twitter. Follow DIA on FaceBook, Twitter, LinkedIn, and YouTube.

Contacts:

Christine Tarlecki
DIA
+1-215-442-6154
Christine(dot)Tarlecki(dot)diahome(dot)org

Joe Krasowski
DIA
+1-215-293-5812
Joe.Krasowski(at)diahome(dot)org

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Christine Tarlecki

Joe Krasowski
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