Skip to main content
 

Resources

Our mission is to serve as a resource of timely, credible information about biosimilars. Please visit this page regularly or follow us on Twitter for the latest updates on Biosimilars infographics, educational material, and FDA regulatory information.

State Laws and Biosimilars

Find out about state laws and legislation related to biologic medications and substitution of biosimilars.

Learn more

Awareness, Knowledge & Perceptions of Biosimilars among Specialty Physicians

View Infographic

Five Things to Know About Biosimilars

View Infographic

Biosimilars: More Treatment Options Are on the Way

FDA article on the impact of biosimilars on access and health

Learn More

Biosimilars Overview

A primer on biosimilar science, regulation, and use

Learn More

Biosimilars FAQs

Answers to Common Questions

Learn More

Biologics Price Competition and Innovation Act of 2009

The abbreviated FDA licensure pathway law

Learn More

FDA Biosimilar Hub

Consumer information about biosimilars

Learn More

Biosimilars: More Treatment Options Are on the Way

FDA article on the impact of biosimilars on access and health

Learn More

FDA Guidance: Scientific Considerations in Demonstrating Biosimilarity

Final guidance to assist biosimilars makers in demonstrating biosimilarity of proposed product to the reference product

Learn More

FDA Guidance: Quality Considerations for Demonstrating Biosimilarity

Final guidance describes FDA’s recommended factors to consider when demonstrating biosimilarity

Learn More

FDA Draft Guidance: Clinical Pharmacology Data Use

Draft FDA guidance to assist with design and use of clinical pharmacology studies to support determination that proposed product is biosimilar to the reference product

Learn More

FDA Draft Guidance: Reference Product Exclusivity

Draft guidance for sponsors developing biological products to help FDA determine date of first licensure for reference product

Learn More

FDA Guidance: Q&A Regarding Implementation of the BPCIA (2015)

Answers to common questions from manufacturers or applicants interested in developing proposed biosimilar products

Learn More

FDA Guidance: Additional Q&A Regarding Implementation of the BPCIA (2015)

Answers to common questions from manufacturers or applicants interested in developing proposed biosimilar products (revised from 2012)

Learn More