Comments to FDA on Labeling for Biosimilar Products | Citizens Against Government Waste

Comments to FDA on Labeling for Biosimilar Products

Agency Comments

May 31, 2016  

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.  

Re: Docket No. FDA-2016-D-0643
“Labeling for Biosimilar Products; Draft Guidance for Industry”  


Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit organization representing more than one million members and supporters nationwide.  CAGW's mission is to eliminate waste, mismanagement, and inefficiency in the federal government.  Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW is the legacy of the President's Private Sector Survey on Cost Control, also known as the Grace Commission.  

CAGW has long understood the importance of patients having access to generic versions of small and large molecule drugs.  Prior to the 1984 passage of the Hatch-Waxman Act, only about 35 percent of brand drugs had competition after their patents expired.  Now, approximately 80 percent of all drugs dispensed in the United States are generics.  According to the Generic Pharmaceutical Association, generic drugs saved the U.S. healthcare system a total of $158 billion in 2010, or $3 billion every week.  A November 2014 Rand Corporation study found that introducing competing biosimilars could save an expected $44 billion between 2014-2024.  


Unlike the United States, much of the world has been using biosimilars for years. The European Union (EU) has had a legal framework for approving biosimilars since 2003 and developed guidelines for biosimilars through an abbreviated registration process between 2005 and 2006.  Europeans have had access to biosimilars since the first one, Omnitrope (somatropin), was approved in 2006.  There are currently 19 biosimilars approved for use in the EU.  

It is important for the United States to catch up with Europe, and CAGW is pleased that the Food and Drug Administration (FDA) is moving forward with guidance on how it wants industry to comply with the Biologics Price Competition and Innovation Act.  We are generally satisfied with the FDA’s March 2016 release of “Labeling for Biosimilar Products; Guidance for Industry,” including the requirement that information on the reference product’s clinical studies on safety and efficacy, rather than data demonstrating biosimilarity, are part of the label.  However, CAGW believes that other provisions will unintentionally create barriers to developing and prescribing biosimilars.  

The labeling guidance should not include a “biosimilarity statement” that the product is a biosimilar to its respective biologic, since it has already been demonstrated through the FDA approval process that there are no clinically meaningful differences between the proposed product and reference product in terms of safety, purity, and potency.  This kind of information is not required in other products that have been found to be therapeutically equivalent.  Adopting such a requirement may send a signal that biosimilars are not as safe or effective as their corresponding brand biologics, and will delay health professional and patient acceptance of biosimilars.  

CAGW continues to be concerned with FDA’s August 2015 guidance on the “Nonproprietary Naming of Biological Products,” which is also reflected in the March 16 guidance for labeling.  The August naming guidance endorses the usage of a core name with a suffix, consisting of four randomly-selected consonants for the reference biologic and all corresponding biosimilars.  CAGW believe this proposed naming procedure will also lead to a slower acceptance of biosimilars.  

CAGW agrees with the Federal Trade Commission that the non-proprietary naming proposal “could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances, especially since differences in drug substance names have traditionally connoted meaningful differences in drug substances.” [1]  CAGW believes that it is better to rely on the biologics’ and biosimilars’ trade names, the products’ unique National Drug Code (NDC) numbers, and the lot numbers as the better approach for pharmacovigilance and adverse event tracking.  

CAGW appreciates the opportunity to comment on FDA’s guidance for biosimilar labeling.  

Tom Schatz
President Citizens Against Government Waste
[1] Comment of the Staff of the Federal Trade Commission - Submitted to the Food and Drug Administration, Department of Health and Human Services, Submitted October 27, 2015. May 26, 2016,   

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