The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) filed a Citizen Petition (“Petition”) with the Food and Drug Administration (FDA) on December 22, 2015. The Petition focuses on the labeling requirements for biosimilar biological products licensed under section 351(k) of the Public Health Service Act (PHS Act), as amended by the Biologics Price Competition and Innovation Act (BPCIA). PhRMA and BIO request labeling requirements that they say “will facilitate informed prescribing, protect against inadvertent substitution, and promote consistency with domestic and international precedents.” Id. at 2. In support of their position, the Petition emphasizes that the requested requirements will provide regulatory transparency to facilitate informed choices by healthcare professionals and patients. The Petition requests that biosimilar product labeling should include the following information and requests that the FDA issue prompt guidance on the issue to this effect. 1. A statement that the product has been approved as a biosimilar for the stated indications and routes of administration and also identifies the reference product. This requirement would ensure that physicians and patients are aware that the product is a biosimilar and its approved uses. In addition to pointing to prior FDA statements regarding the importance of this information for doctors and prescriber survey results showing the perceived importance of this information, the Petition notes that FDA regulations require that “a medicine’s prescribing information must contain ‘a summary of the essential scientific information needed for the safe and effective use of the drug.’” Petition at 3 (citing 21 C.F.R. § 201.56(a)(1)). 2. A description of the relevant data (clinical and nonclinical) for the reference product and biosimilar that support the biosimilar finding This requirement would ensure that physicians are fully informed when assessing prescribing options and “avoid misimpressions about the product studied in each trial.” Id. at 4. Prescriber survey results also indicated that this information was important to “distinguish data generated by the biosimilar and reference product sponsors” and to identify “which indications were studied by the biosimilar sponsor.” Id. This information would also clarify if a biosimilar was approved in an indication on the basis of clinical data or on some other basis. The Petition points to the approved labeling of Omnitrope® (somatropin [rDNA original] for injection), a follow-on protein product approved under a Federal Food, Drug, and Cosmetic Act (“FDCA”) section 505(b)(2) application, as an example of labeling consistent with this requirement, noting the similarities between biosimilars and follow-on protein products and the future transition of approval for follow-on protein products under section 351(k). 3. A statement on whether the product has been determined to be interchangeable with a reference product. Requiring that labeling indicates whether a determination of interchangeability for a biosimilar has support both in prior FDA statements and prescriber survey results. The Petition submits that including this information will guard against inadvertent substitution, which can create health risks for patients (as previously noted by the FDA). The Petition also notes that the determination for interchangeability is not the same as that for a biosimilar and, thus, different labeling may help avoid confusion over whether a product is substitutable. The Petition also requests that updates for biosimilar labeling be required to provide for information learned about the product once in the market and changes to indication approval for the reference product. A response to the Petition is required within 180 days. However, the Petition raises issues that may require additional time and coordination within the agency, giving the number of petitions involving biosimilars that have been recently filed.  A copy of the Petition is available here. Download PDF
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