The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products.

What is a biosimilar product?

Biosimilar products are biological products that are highly similar to an FDA-approved biological product, known as a reference product. Notwithstanding minor differences in clinically inactive components, there can be no clinically meaningful differences between the biological product and the reference product in terms of the safety and efficacy.  In 2010, the Biologics Price Competition and Innovation Act (“BPCIA”) was enacted as part of the Affordable Care Act in order to provide an abbreviated licensure pathway for a biosimilar that partly relies on the data originally submitted to the FDA by the reference product sponsor for approval.

What is the status quo?

Currently, an application submitted under the abbreviated licensure pathway for a proposed biosimilar must contain, among other things, information demonstrating that the proposed product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and clinical studies or studies sufficient to demonstrate safety, purity and potency in certain conditions. Additionally, under FDA regulations, prescription drug labeling must provide adequate information to enable health care practitioners to use the drug safely and for the purposes for which it is intended.

What does the draft guidance propose?

In short, the draft guidance proposes recommendations for prescription drug labeling that pertains to the prescribing information (commonly referred to as the package insert), as well as FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). Most notably, FDA recommends that labeling for biosimilars incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications, and include a description of the clinical data that supported safety and efficacy of the reference product.  FDA emphasizes that data from clinical studies designed to support a demonstration of biosimilarity are not likely to be relevant to a health care practitioner’s considerations regarding safe and effective use of the biosimilar product and therefore should not be included in the labeling.

Other key recommendations proposed by the draft guidance include the following:

  • FDA recommends that the biosimilar product name (e.g., the proprietary name if one exists) be used in labeling text that is specific to the biosimilar product or refers solely to the biosimilar product.
  • The labeling for the biosimilar product should be specific to the conditions of use (e.g., indication(s), dosing regimen(s) sought for the biosimilar product) and should be consistent with language previously approved for the reference product for those conditions of use.
  • FDA recommends including a “biosimilarity statement” in biosimilar product labeling indicating that the product is biosimilar to the reference product on the line immediately beneath the initial U.S. approval date in “Highlights.”
  • Information in “Indications and Usage” should be specific to the approved indications for the biosimilar product and should be consistent with language previously approved for the reference product for those indications.
  • FDA recommends using the reference product’s proper name in labeling information when clinical studies or data derived from studies with the reference product are described in the biosimilar product labeling.
  • The draft guidance proposes instructions with regard to submitting initial and revised labeling.

FDA provides several examples of its recommendations throughout the guidance.

The draft guidance does not include specific labeling recommendations for interchangeable biological products. However, the FDA notes in the guidance that the Agency is considering data and information that would support the interchangeability of biosimilars, or the ability of pharmacists to substitute the drugs for brand-name medications without fear of any adverse effects.

Comments to the draft guidance should be submitted by June 3, 2016 at