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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.

States Continue to Pass Biosimilar Substitution Laws in 2018

“The Biosimilars Forum is encouraged that so far this year, five more states – Michigan, South Dakota, West Virginia, Wisconsin and Wyoming – have enacted legislation that will help their residents and health care systems benefit from the promise of biosimilars. With 41 states now having passed biosimilar laws allowing substitution of biosimilars designated as interchangeable, patients and doctors can be encouraged that in most states, pathways which support access to these affordable and effective treatment options are taking shape.

“We look forward to policymakers at both the state and federal level continuing to play a role in developing a vibrant biosimilars market, which could lead to a transformation in the way Americans manage serious diseases including cancer, diabetes, rheumatoid arthritis and other chronic conditions.” - Juliana M. Reed, President, Biosimilars Forum.

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FDA Information on Prescribing Biosimilars

FDA information regarding the prescribing of biosimilars

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FDA Information on Prescribing Interchangeable Biosimilar Products

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State Laws and Biosimilars

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

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Awareness, Knowledge & Perceptions of Biosimilars among Specialty Physicians

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Five Things to Know About Biosimilars

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Biosimilars Overview

A primer on biosimilar science, regulation, and use

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Biosimilars FAQs

Answers to Common Questions

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Biologics Price Competition and Innovation Act of 2009

The abbreviated FDA licensure pathway law

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FDA Biosimilar Hub

Consumer information about biosimilars

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Biosimilars: More Treatment Choices and Innovation

FDA article on the impact of biosimilars on access and health

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FDA Guidance: Scientific Considerations in Demonstrating Biosimilarity

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

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FDA Guidance: Quality Considerations for Demonstrating Biosimilarity

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

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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

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FDA Draft Guidance: Reference Product Exclusivity

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

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

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

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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)

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