Assistance for applicants that are developing draft labeling for proposed biosimilar products has finally arrived. Specific recommendations for labeling, particularly for prescribing information on the package insert, for biosimilar products that fall under Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)), as well as an explanation of biosimilarity and labeling of these products in general, were included in an advance release of a draft guidance.
The draft guidance will be published in the Federal Register on April 4, 2016. In the guidance, the FDA noted it was seeking comments on the guidance and highlighted a specific comment area for industry stakeholders to provide responses to. The FDA also released an explanatory biosimilar product labeling perspective to guide developers.
Legislative history. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted pursuant to the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), amended the PHS Act and created an “abbreviated licensure pathway for biosimilar products.” That is, if a product can be shown to be biosimilar or interchangeable with an already-licensed reference product, it may be a candidate for this expedited avenue to obtaining licensure with the FDA.
Biosimilarity. As it is explained in the draft guidance, Section 351(i) of the PHS Act defines biosimilarity as meaning, “that the product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.” Moreover, to be biosimilar to the reference product, it must not have any clinically meaningful differences with regard to safety, purity, and potency. To be considered as a biosimilar a product application must contain information proving biosimilarity that is based on: (1) analytical studies demonstrating that the biosimilar product is highly similar to the reference product; (2) animal studies; and (3) clinical studies that demonstrate safety, purity, and potency. Moreover, a biosimilar product must provide drug labeling that is a sufficient to allow practitioners to “use the drug safely and for the purposes for which it is intended.”
Labeling, in general. First, the draft guidance set forth general principles of biosimilar labeling, notably that relevant data and information from the reference product labeling be included. Because information and data from a clinical study should only be included on labeling if it is necessary in order to ensure safe and effective use by a practitioner, the FDA recommended that “biosimilar product labeling should only include a description of the clinical data that supported the safety and efficacy of the reference product as described in the FDA-approved product labeling for the reference product.” Moreover, the draft guidance explained that biosimilar labeling must be in conformance with the regulations at 21 C.F.R. Secs. 201.56(d) and 201.57.
Specific recommendations. Next, the draft guidance provided more detail and specific recommendations for biosimilar draft guidance. In terms of approaching product identification, the agency says that this depends on the context of the information presented. In discussing the approach, the agency explains suggestions around these situations:
- when to use the biosimilar product name;
- when to use the reference product name;
- when to use the core name, or “the product shared among the related biological products as part of the proper name;” and
- when to use more than one product name.
The FDA also explored approaches to content presentation, and in general, recommended that the labeling for the biosimilar product should be specific to the product’s condition of use, and once again, should reflect the language of the labeling that was previously approved for the reference product. In terms of approaches to specific sections of labeling, the draft guidance described what type of information should be in the following sections: (1) highlights of the prescribing information; (2) indications and usage; and (3) adverse reactions. The draft guidance also covered what FDA-approved patient labeling should entail, or what to do if a Medication Guide is required, and how to revise biosimilar product labeling.
Comments. While the FDA stated that it would invite general comments on the draft guidance it also specifically asked for comments on one topic. Specifically, it asked whether patient labeling, including Patient Information, Medication Guide, and Instructions for Use sections, should include a biosimilarity statement similar to the one described in other parts of the draft guidance.
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