PhRMA and BIO Citizen Petition to FDA calls for biosimilar labeling guidance

Biosimilars will continue to become more widely available to patients in 2016 and beyond.  PhRMA supports science-based regulation of biosimilars by the Food and Drug Administration (FDA). However, critical guidance on how they should be labeled to ensure regulatory transparency and accurate prescribing has yet to be issued by the Agency. 

In a Citizen Petition to the FDA filed on December 22, 2015, PhRMA and the Biotechnology Innovation Organization (BIO) urged the Agency to include a number of key safety and transparency features – perhaps most critically a statement of biosimilarity within the FDA-approved labeling of a biosimilar that names the biosimilar’s reference product (the innovative drug on which the biosimilar is based) – as FDA develops regulatory guidance on this issue.

PhRMA’s and BIO’s requests outlined in the Citizen Petition include the following:

• Biosimilar labeling should state that the drug has been approved as a biosimilar for the stated indications and routes of administration and identify the reference product. Requiring a statement of biosimilarity will foster regulatory transparency and informed prescribing decisions.

• Biosimilar labeling should describe the basis of approval for each indication by identifying the relevant data for the reference product and biosimilar that support a finding of biosimilarity. It’s important for health care providers to understand the basis of the FDA’s decisions so that they are fully informed prior to making prescribing decisions. Health care professionals should also be able to review in labeling a summary of the data for both the innovator reference drug as wells as data supporting the approval of the biosimilar product.

• Biosimilar labeling should include a statement on whether or not FDA has made a determination of interchangeability with the reference product and include any such FDA finding. “Interchangeability” means that a pharmacist could provide a patient with the biosimilar rather than a reference product without first consulting the prescriber or informing the patient. The FDA has previously recognized that this information is “necessary for a health professional to make prescribing decisions.” Such meaningful transparency is critical, because unlike generic drugs, biosimilars are not always interchangeable with their reference product. Requiring a statement of interchangeability will help protect patients from inadvertent substitutions and promote safe use of these medicines.

In a briefing for U.S. senators in September 2015, FDA promised to issue guidance on labeling of biosimilars, but has yet to do so. A response to the PhRMA/BIO Citizen Petition is required within 180 days.

For more information on biologics and biosimilars, go to: www.phrma.org/biosimilars.