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United States Resources

The Patient Protection and Affordable Care Act

Organizations that rejected interchangeability for biologics in legislative debate:

Outside United States (EU and Other)

European Union Biosimilar Medicines

European Medicines Agency (EMA) Guidelines — Including Draft & Adopted Guidelines

European Medicines Agency (EMA) – Pharmacovigilance: Regulatory and procedural guidance

European Medicines Agency (EMA) – European Public Assessment Reports (EPARs) – Biosimilar Applications

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 You will also find information on medicines which were refused a marketing authorization or have been suspended or withdrawn post-approval.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.

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Withdrawn Post-Approval Products — Full Listing

International Non-proprietary Name (INN) Trade Name Owner Withdrawn Date Ref.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