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)
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
Outside United States (EU and Other)
European Union Biosimilar Medicines
European Medicines Agency (EMA) Guidelines — Including Draft & Adopted Guidelines
- Overarching biosimilar guidelines
- Product specific biosimilar guidelines
- Other guidelines relevant for biosimilars
European Medicines Agency (EMA) – Pharmacovigilance: Regulatory and procedural guidance
Once a medicine has been granted a European Community marketing authorization by the European Commission, the European Medicines Agency publishes a full scientific assessment report called a European Public Assessment Report (EPAR). In the EPAR, you will find key information for a medicine including a Q&A on the medicine and the patient leaflet. You will also find information on medicines which were refused a marketing authorization or have been suspended or withdrawn post-approval. Please be aware that the Agency does not evaluate all medicines currently in use in Europe, therefore no EPAR will be available for medicines approved prior to 2004.
Each EPAR record provides information on individual medicines including: general information about the medicine, a summary of the EPAR, authorization details, product information (including clinical trial summaries) and an assessment history. An example of how the information available for each medicine is displayed can be viewed here.
- European Public Assessment Report (EPAR) — Authorized Medicines
- European Public Assessment Report (EPAR) — Withdrawn Post-Approval
- European Public Assessment Report (EPAR) — Suspended
- European Public Assessment Report (EPAR) — Refused
Approved Products — Full Listing
International Non-proprietary Name (INN) | Trade Name | Owner | Approval Date | Ref. Product |
Somatropin | Omnitrope | Sandoz | 4-12-06 | Genotropin |
Somatropin | Valtropin | Bio Partners | 4-24-06 | Humatrope |
Epoetin Alfa | Binocrit Epoetin Alfa Hexal Abseamed |
Sandoz Hexal Medice |
8-28-07 8-28-07 8-28-07 |
Eprex |
Epoetin Zeta | Retacrit Silapo |
Hospira Strada |
12-18-07 12-18-07 |
Eprex |
Filgrastim | Tevagrastim Biograstim Ratiograstim Filgrastim |
Teva CT Arzneimittel Ratio Pharma Ratio Pharma |
9-15-08 9-15-08 9-15-08 9-15-08 |
Neopogen |
Filgrastim | Zarzio Filgrastim Hexal |
Standoz Hexal |
2-6-09 9-15-08 |
Neupogen |
Filgrastim | Nivestim | Hospira | 6-8-10 | Neupogen |
Refused Products – Full Listing
International Non-proprietary Name (INN) | Trade Name | Owner | Refusal Date | Ref. Product |
Interferon-alfa-2a | Alpheon | Bio Partners | 5-9-06 | Roferon-A |
Withdrawn Post-Approval Products — Full Listing
International Non-proprietary Name (INN) | Trade Name | Owner | Withdrawn Date | Ref. Product |
Insulin – Human | Insulin Rapid | Marvel LifeSciences | 6-16-08 | Humulin |
Insulin – Human | Insulin 30/70 Mix | Marvel LifeSciences | 6-16-08 | Humulin |
Insulin – Human | Insulin Long Acting | Marvel LifeSciences | 6-16-08 | Humulin |
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)