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Moving Beyond Theory — Strategic and Tactical Decisions for Long-Term Success

January 23-24, 2018
  • Alexandria, VA
NEW FDA Draft Guidance —
Statistical Approaches to Evaluating Similarity for Biosimilars

The FDA released draft guidance on September 21, 2017 regarding information a sponsor should obtain about the structural/physiochemical and functional attributes of a reference products, how information is used in development of an analytical similarity assessment plan and statistical approaches recommended for evaluating analytical similarity. Review the draft guidance now.

With more U.S. biosimilars continuing to receive FDA approval, it is critical that bio/pharmaceutical companies develop strategies to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success. CBI’s 13th Biosimilars Summit is the leading event to continually stay on the pulse of the biosimilars’ ever-changing market and convenes key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers, providers and patient advocates addressing timely challenges and best practices for biosimilar product success.

GAIN CRITICAL INSIGHTS ON:

  • PBM and Payer Biosimilar Uptake
  • Remicade Lawsuit Case Study
  • Healthcare Common Procedure Coding System
    (HCPCS) J Codes Billing System
  • Sandoz v. Amgen SCOTUS Ruling
  • FDA’s Interchangeability Draft Guidance
  • Navigating the “Patent Dance”
  • Economic Approach to Develop Biosimilars for
    Your Own Innovator Drug
  • International Biosimilars Pipeline
Benefit from an Elite Speaking Faculty, Including:

Amgen • Boehringer Ingelheim • Biogen • Coherus BioSciences • GlaxoSmithKline
Life Science Connect • Living Pharma • Merck • Momenta Pharmaceuticals
National Association of Specialty Pharmacy • Biotechnology Industry Organization • District of New Jersey Attorney General (retired)
Association for Accessible Medicines • National Business Group on Health
Patients for Biologics Safety and Access • Trinity Partners, LLC
University of Portsmouth • Widener University

ACCLAIM FOR INDUSTRY’S MUST-ATTEND EVENT:

13th Biosimilars Summit

Moving Beyond Theory — Strategic and Tactical Decisions for Long-Term Success

NEW FDA Draft Guidance —
Statistical Approaches to Evaluating Similarity for Biosimilars

The FDA released draft guidance on September 21, 2017 regarding information a sponsor should obtain about the structural/physiochemical and functional attributes of a reference products, how information is used in development of an analytical similarity assessment plan and statistical approaches recommended for evaluating analytical similarity. Review the draft guidance now.

With more U.S. biosimilars continuing to receive FDA approval, it is critical that bio/pharmaceutical companies develop strategies to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success. CBI’s 13th Biosimilars Summit is the leading event to continually stay on the pulse of the biosimilars’ ever-changing market and convenes key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers, providers and patient advocates addressing timely challenges and best practices for biosimilar product success.

GAIN CRITICAL INSIGHTS ON:

  • PBM and Payer Biosimilar Uptake
  • Remicade Lawsuit Case Study
  • Healthcare Common Procedure Coding System
    (HCPCS) J Codes Billing System
  • Sandoz v. Amgen SCOTUS Ruling
  • FDA’s Interchangeability Draft Guidance
  • Navigating the “Patent Dance”
  • Economic Approach to Develop Biosimilars for
    Your Own Innovator Drug
  • International Biosimilars Pipeline
Benefit from an Elite Speaking Faculty, Including:

Amgen • Boehringer Ingelheim • Biogen • Coherus BioSciences • GlaxoSmithKline
Life Science Connect • Living Pharma • Merck • Momenta Pharmaceuticals
National Association of Specialty Pharmacy • Biotechnology Industry Organization • District of New Jersey Attorney General (retired)
Association for Accessible Medicines • National Business Group on Health
Patients for Biologics Safety and Access • Trinity Partners, LLC
University of Portsmouth • Widener University

ACCLAIM FOR INDUSTRY’S MUST-ATTEND EVENT: