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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

INTRODUCTION

This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product (hereinafter proposed product2) is biosimilar to a reference product for purposes of the submission of a marketing application under section 351(k) of the Public Health Service Act (PHS Act).3 The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the PHS Act and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Affordable Care Act) (Public Law 111-148). Although the 351(k) pathway applies generally to biological products, this guidance focuses on therapeutic protein products and gives an overview of important scientific considerations for demonstrating biosimilarity. The scientific principles described in this guidance may also apply to other types of proposed biosimilar biological products.

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