Critical Issues Related to Regulation of Follow-on Biologics

Sponsored by sanofi aventis, this conference focused on the new health care reform law and its provisions for approval and substitutability of follow-on biologics (also known as biosimilars).

On December 15, 2011, the Center on Drugs and Public Policy (CDPP) at the University of Maryland School of Pharmacy hosted an invitational conference entitled "Critical Issues Related to Regulation of Follow-on Biologics." This conference was held at the Washington Marriott at Metro Center in Washington, DC. For more information about this conference, including the conference program, presentations, and related guidances, please explore the links below.

Executive Summary
Conference Program
Presentations
- Critical Issues Related to Regulation of Follow-on Biologics: An Overview of the New Statutory and Regulatory Environment for Biosimilars
  Robert A. Dormer, Esq.
  Hyman, Phelps & McNamara, PC
- Balancing Access and Patient Safety
  Sheila Weiss Smith, PhD
  University of Maryland School of Pharmacy
- Pharmacovigilance, Risk Management, Registries and Biosimilars
  Annette Stemhagen, DrPH, FISPE
  United BioSource Corporation
- Follow-on Biologics (Biosimilars): Review of the European Regulatory Experience
  Bruno Flamion, MD, PhD
  Belgian Committee for Reimbursement of Medicines
- Critical Issues Related to Regulation of Follow-on Biologics: FDA Directions
  Sheila D. Walcoff, Esq.
  Goldbug Strategies, LLC
Guidances