and Jennifer Giordano-Coltart, Ph.D.
The Food and Drug Administration (FDA)’s long-awaited draft guidance
(Draft Guidance) on biosimilar product labeling was finally issued on March 31, 2016. The Draft Guidance addresses product labeling requirements for biosimilar products approved under Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. § 262(k)), referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
In the Draft Guidance, FDA tries to take a balanced approach to the labeling for biosimilar products. On the one hand, FDA indicates that labels should state that the product is a biosimilar and identify the reference product. On the other hand, FDA is not in favor of including information or data from the clinical studies used to support the licensure of the biosimilar except as necessary for safe and effective use
FDA anticipates that the biosimilar product labeling will reflect the text of the reference product labeling but need not be identical. Generally, “biosimilar product labeling should incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications” (e.g.
, indication(s), dosing regimen(s), condition(s) of use different from the reference product). See
Guidance at 1. In particular, labels for biosimilar products should include a description of the clinical data supporting the safety and efficacy of the reference product. Labeling will generally not include text relating to indications for which the biosimilar has not sought licensure unless necessary to help ensure safe use of the product. In addition, possibly to address concerns raised by Abbvie Inc.,[ii]
FDA indicates that a statement regarding the risk of immunogenicity be included in the adverse reactions section of the label. Interestingly, the Draft Guidance outlines scenarios where labeling may make reference to the biosimilar product name (e.g.
, proprietary name), the proper name, and/or the core name in the HIGHLIGHTS OF PRESCRIBING INFORMATION section of the label.[iii]
Labeling text that is specific to the biosimilar product, or refers solely to the biosimilar product, should use the product name or, if there is no proprietary name, the proper name for the biosimilar product. However, where the label refers to clinical studies or data relating to the reference product, the reference product’s name should be used. The reference product name should also be used in the label statement identifying the product as a biosimilar of the reference product. In contrast, the core name should be used on the label when referring to the overall risk-benefit profile of the reference product, which FDA states “is relevant to the biosimilar product, even if a particular serious adverse reaction or other risk included in the reference product labeling may not have been reported with the biosimilar product at the time of licensure.” Draft Guidance at 6. Lastly, FDA states that there will be scenarios where more than one product identification approach may be appropriate if needed to accurately convey information on the label. The Draft Guidance also discusses FDA-approved patient labeling (must follow regulations if a Medication Guide is required), revising biosimilar product labeling (e.g.
, to update safety information or add additional conditions of use), and submission of initial and revised labeling. This Draft Guidance only applies to biosimilar products, e.g.
, those that are “highly similar” to the licensed reference product that is relied on in the 351(k) application. The Draft Guidance does not address interchangeable products. Compared to biosimilars, interchangeable product applicants have a higher but yet undefined standard by which they must provide sufficient information to demonstrate interchangeability. Applicants must also be able to demonstrate that the product can be expected to produce the same clinical result as the reference product in any given patient and, and that the risk is not greater than the risk presented by the reference product alone, if the patient alternates or switches between products. See
PHS Act § 351(k)(4). Importantly, interchangeable products can be substituted by pharmacists for the reference product without the intervention of the prescribing health care provider. See
PHS Act § 351(i)(3). Comments and suggestions regarding the Draft Guidance should be submitted by June 3, 2016.[iv] Download PDF
Thus, FDA has declined to follow the recommendation of Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO), who filed a joint Citizen Petition calling for a description of the data that supported a biosimilar finding. See
prior post on PhrMA/BIO Citizen Petition here
AbbVie submitted a Citizen Petition on the standard for establishing interchangeability of a biosimilar product on December 16, 2015. A copy of the Citizen Petition is available here
. See also
prior post on AbbVie Citizen Petition here
The “core name” is the “component shared among related biological products,” while the “proper name” of the biosimilar is the “nonproprietary name designated by FDA in the license,” which includes “a designated suffix composed of four lowercase letters attached to the core name with a hyphen.” Guidance at 6, n. 13, 14. Of note, FDA has not been swayed by the industry response to the proposed proper name format for biosimilar products set forth in the draft guidance entitled Nonproprietary Naming of Biological Products
, issued on August 27, 2015. See
Jeff Overley, On Biosimilar Names, FDA Charts Middle Course
, Law360, Aug. 27, 2015, available at http://www.law360.com/articles/696051/print?section=lifesciences
. A copy of the August 27, 2015 draft guidance is available here
The Notice of Availability in the Federal Register and information regarding submission of comments is available here