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Our mission is to serve as a resource of timely, credible information about biosimilars. Please visit this page regularly to find regulatory information, backgrounders, infographics, and more.

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 Options Are on the Way

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FDA Draft Guidance: Clinical Pharmacology Data Use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FDA Draft Guidance: Reference Product Exclusivity

Draft guidance for sponsors developing biological products to help FDA determine date of first licensure for reference product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