FDA
United States Resources
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 Presentation: U.S. Approval Pathway for Biosimilar Biological Products
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)