United States Resources

 

BioProcess Special Report — Biosimilars in Development: Current Views on Manufacturing, Analytics, and Commercialization

The Patient Protection and Affordable Care Act

FDA Statement of Organization, Functions, and Delegations of Authority

FDA Notice of Public Hearing Approval Pathway for Biosimilar and Interchangeable Biological Products and Request for Comments – November 2010

FDA Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products – Submission of Comments Section – November 2010

FDA Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products – Transcript – November 2010

FDA Presentation: U.S. Approval Pathway for Biosimilar Biological Products

National Physicians Biologics Working Group White Paper — Biologics: A Different Class of Medications That Makes A Difference for Our Patients

 

Organizations that rejected interchangeability for biologics in legislative debate:

General Resources