Update on FDA’s Approach to Labeling Biosimilars Like Generics

by Patterson Belknap Webb & Tyler LLP

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns.  Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s Neupogen and that it has not been determined to be interchangeable to Neupogen.  Instead, Zarxio’s label is nearly identical to that of Amgen’s Neupogen and does not identify the information provided by Sandoz to FDA to obtain Zarxio’s approval, including information on immunogenicity specific to Zarxio. AbbVie Inc. has supplemented its citizen petition urging FDA not to allow biosimilars to be labeled like generic drugs since biosimilars, unlike generic drugs, are not identical to the originator product and requesting distinct labeling for biosimilars.  In briefing U.S. senators on September 17, FDA promised to issue guidance on labeling of biosimilars.

In its June 2, 2015 citizen petition, AbbVie stated that FDA’s approach to labeling biosimilars was inconsistent with the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which recognizes that biosimilars are not the same as their reference products, and results in labeling that omits material information contrary to the Federal Food, Drug, and Cosmetic Act (FDCA).  AbbVie requested FDA to ensure that biosimilar product labels contain: 1) a “clear statement that the product is a biosimilar, that the biosimilar is licensed for fewer than all the reference product’s conditions of use (if applicable), and that the biosimilar’s licensed conditions of use were based on extrapolation (if applicable);” 2) a “clear statement that the FDA has not determined that the biosimilar product is interchangeable with the reference product (if applicable);” and 3) a “concise description of the pertinent data developed to support licensure of the biosimilar, along with information adequate to enable prescribers to distinguish data derived from studies of the biosimilar from data derived from studies of the reference product.”  In August, AbbVie supplemented its petition to address subsequent events and information.

In its supplement, AbbVie addressed FDA’s statements to the Senate Committee on Health, Education, Labor and Pensions (“HELP Committee”) in response to a letter from the HELP Committee regarding FDA’s approach to implementing the BPCIA.  Among other things, the HELP Committee’s letter objected to the fact that the label for Zarxio had no statement concerning the product’s interchangeability status and did not even include the word “biosimilar.”  Further, the letter raised concern about the final version of FDA’s April 2015 guidance entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,” which deleted all discussion of what a biosimilar product label should say about interchangeability.

In its June 22, 2015 response, FDA stated that interchangeability information did not need to be included in biosimilar labeling because prescribers could obtain the omitted information from the FDA’s “Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” which identifies Zarxio as a biosimilar.  AbbVie described this proposition as “indefensible” because “FDA regulations explicitly state that prescription drug labeling found ‘on or within the package’ (in other words, the package insert) must contain all of the information that prescribers require to administer the drug to their patients safely and effectively.” (citing 21 C.F.R. § 201.100(c)(1) (emphasis in supplement).  Additionally, AbbVie noted that FDA’s reliance on The Purple Book as an ancillary source of information is “curiously irrational,” as the labeling does not even tell prescribers that the product is a biosimilar in the first instance and therefore provides no reason to consult The Purple Book.

AbbVie also pointed to statements made by FDA and the Department of Justice (DOJ) in Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y.) regarding the new drug Vascepa®. In a brief filed with the court on June 23, 2015, the DOJ (on FDA’s behalf) asserted that it would be “misleading for Amarin to suggest or imply . . . that studies using products other than Vascepa were studies of Vascepa itself.”  AbbVie noted that these statements highlight the significant shortcomings in FDA’s current approach to biosimilar labeling.  That is, the current approach does not take into account that a biosimilar and its reference product are not the same active ingredients or products.  Instead, the labeling for Zarxio relies on studies involving a different product, Amgen’s Neupogen, without stating that the studies were not conducted with Zarxio.  AbbVie stated that, as FDA and DOJ have acknowledged, the failure to disclose that studies were conducted using other products is misleading.

AbbVie’s supplement also described significant stakeholder support for distinct labeling of biosimilars.  AbbVie noted that its position is supported by, among other things, three recent letters to the Acting Commissioner of FDA from groups representing pharmacists and patients, survey evidence, an Alliance for Patient Access conference on Capitol Hill, and a recent statement from the Biosimilars Forum – an organization comprising “the majority of companies with the most significant U.S. biosimilars development portfolios.”

On September 17, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, briefed U.S. Senators about developments in implementing the BPCIA.  Woodcock stated that FDA would be providing an upcoming guidance on the labeling of biosimilars.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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