If you are starting the process of learning about the specific guidelines for a regulatory agency’s review of biosimilars, below are some links to help you start the process.


World Health Organization (WHO)

WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products

Biological Qualifier (BQ) — An INN Proposal


Food and Drug Administration (FDA): US

Types of Applications for Drug Approval 

FDA’s Biosimilar Page

Biosimilar Information for Consumers

Biosimilar Information for Healthcare Professionals

Biosimilar Information for Industry

FDA Guidance on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (Draft Guidance)

FDA Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Draft Guidance)

FDA Guidance on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (Draft Guidance)

The Purple Book — Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009


European Medicines Agency (EMA): Europe 

Biosimilars Page

Biosimilars Approved by the EMA 

EMA’s Scientific Guidelines on Biosimilar Medicines 


Pharmaceuticals Medical Devices Agency (PMDA): Japan

Regulations of Biosimilars in Japan

Guidance documents


Health Canada

Guidance - Information and Submission Requirements for Subsequent Entry Biologics (SEBs)

Fact Sheet: Subsequent Entry Biologics (SEBs) in Canada

Questions & Answers To Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)


Department of Health, Therapeutic Goods Administration: Australian Government

Evaluation of Biosimilars


Biosimilars vs. Generics
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How are Biosimilars Approved?
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