The U.S. FDA has released draft guidelines on labeling of biosimilars but problems remain in world’s biggest biopharma market.
This guidance is intended to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for recommendations in section V pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use).
Specific labeling recommendations for interchangeable biological products are not provided in this guidance. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
In the guidance document, the FDA says that to meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
Interchangeable products may be substituted for the reference product without the intervention of the prescribing health care provider, FDA says.
The document said: “Information and data from a clinical study of a proposed biosimilar product should be described in its labeling only when necessary to inform safe and effective use by a healthcare practitioner.”
“As a general matter, it is FDA’s view that biosimilar product labeling should not include a description of these data, given that a clinical study supporting the licensure of the biosimilar product generally would not be designed to independently demonstrate the safety and efficacy of the product, but rather to support a demonstration that there are no clinically meaningful differences between the proposed biosimilar product and the reference product for the approved.”
The draft guidance, which is waiting for comments from the industry can be found here.