Labeling Debate Hones in on Biosimilarity Statement

June 21, 2016

Stakeholders are divided over a provision of the Food and Drug Administration’s draft regulatory guidance on biosimilar labeling, letters to the FDA reveal. Specifically, insurers and patient advocates disagree about the value – and necessity – of including a statement that identifies biosimilars as such in their prescribing information. The agency’s decision on whether to maintain the statement could test the FDA’s commitment to transparent labeling for the innovative drugs.

[READ: FDA’s Draft Biosimilar Labeling Guidance Falls Short on Patient Safety Measures]

In a June 3 letter to the FDA, the Generic Pharmaceutical Association suggested that the FDA’s proposed statement of biosimilarity could confuse physicians and jeopardize cost savings. The letter also argues that the statement is “not one of the most important pieces of information about a biosimilar product.” A separate letter from 11 insurers and supply chain stakeholders, including Express Scripts and Blue Cross Blue Shield Association, echoed these sentiments. The biosimilarity statement sends “mixed signals to providers,” the signatories explain.

Patient advocates take a different view.

In a separate letter to the FDA, Patients for Biologics Safety and Access reiterated the importance of giving health care providers as much information as possible about biosimilars. “We are pleased that the guidance requires products to be clearly labeled as biosimilars,” PBSA’s letter explains.

Meanwhile, the Alliance for Patient Access notes that “Congress, the Food and Drug Administration (FDA), and the World Health Organization (WHO) have repeatedly affirmed that biosimilars… [cannot] be treated as identical to their reference biologics… It follows, then, that labeling policy for biologic therapies must provide sufficient information to permit physicians and patients to discern these therapies’ differences.”

[WATCH: What Physicians Need to Know to Safely Prescribe Biosimilars]

Patient advocates have argued that transparency will inform physicians and increase their confidence in prescribing new biosimilars. Toward that end, advocacy organizations encourage the FDA to add, alongside the biosimilarity statement, a statement on whether the biosimilar has been deemed interchangeable by the FDA.

Patient advocates have also requested that the FDA add clinical trials information from the biosimilar rather than featuring only trials information from the reference product. Given that a single biologic or biosimilar can treat a range of dissimilar diseases, physicians could use full and transparent clinical trials data to make determinations about which therapy best suits a given patient.

The FDA extended the comment period for its biosimilar labeling guidance until Aug. 2

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