United States Resources

List of Biosimilars Approved in the U.S. (FDA)

FDA Guidances Related to Biosimilars

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

The Patient Protection and Affordable Care Act

• Biosimilars sections are on page 321 (Section 3139) dealing with payment for biosimilars
• Biosimilars framework is provided starting on page 686 (section 7001-7002)

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:

• American Association of Clinical Endrocrinologists
• American Academy of Dermatology Association
• American Association of Neurological Surgeons
• American Association of Orthopaedic Surgeons
• American College of Emergency Physicians
• American College of Obstetricians and Gynecologists
• American College of Rheumatology
• American Gastroenterological Association
• American Society for Therapeutic Radiology and Oncology
• American Society of Cataract & Refractive Surgery
• American Urological Association
• Coalition of State Rheumatology Organizations
• Congress of Neurological Surgeons
• Heart Rhythm Society
• National Association of Spine Specialists
• Medical Society of New Jersey

General Resources

• Biotechnology Industry Organization (BIO)
• Congressional Budget Office (CBO)
• European Medicines Agency (EMA)
• Federal Trade Commission (FTC)
• Generic Pharmaceutical Association (GPhA)
• National Physicians Biologics Working Group
• The Pharmaceutical Research and Manufacturers of America (PhRMA)
• U.S. Food and Drug Administration (FDA)
• U.S. Food and Drug Administration — Biosimilars Information Section
• World Health Organization (WHO)