Office of New Drugs, Therapeutic Biologics and Biosimilars Staff, in the
Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and
Research (CBER) at the Food and Drug Administration

First published July 2018

I. INTRODUCTION

This guidance is intended to help applicants develop draft labeling for proposed biosimilar
products for submission in an application under section 351(k) of the Public Health Service Act
(PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this
guidance pertain only to the prescribing information (commonly referred to as the package
insert), except for certain recommendations in section V pertaining to FDA-approved patient
labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). This guidance
does not provide specific labeling recommendations for interchangeable products (see
section VIII of this guidance).

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.

II. BACKGROUND

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted as part of
the Patient Protection and Affordable Care Act (Affordable Care Act) (Public Law 111-148) on
March 23, 2010. The BPCI Act amends the PHS Act and other statutes to create an abbreviated
licensure pathway for biological products shown to be biosimilar to or interchangeable with an
FDA-licensed reference product (see sections 7001 through 7003 of the Affordable Care Act).
Section 351(k) of the PHS Act, added by the BPCI Act, sets forth the requirements for an
application for a proposed biosimilar product and an application or a supplement for a proposed
interchangeable product.

Section 351(i) of the PHS Act defines biosimilarity to mean “that the biological product is highly
similar to the reference product notwithstanding minor differences in clinically inactive
components” and that “there are no clinically meaningful differences between the biological
product and the reference product in terms of the safety, purity, and potency of the product.”

Read the full guidance letter here.