Drugs

Advocacy Groups Urge Consistent Biosimilar Naming

Nine healthcare advocacy organizations representing pharmacists, pharmacies, payers, pharmacy benefit managers, and other stakeholders have written to key members of both the House and Senate to express concern about an FDA proposal to exempt certain biologic products, including biosimilars, from requirements to adhere to U.S. Pharmacopeial (USP) public standards for quality, including the naming of biologic and biosimilar medicines. The groups’ 8/1 letter says that approaches that deviate from a single source to identify the non-proprietary naming of biologics affect the ability of healthcare practitioners to clearly communicate health information and protect patients from misbranded and adulterated medications.

“The current system establishes USP as the primary entity to develop and establish names in the United States consistent with global standards for non-proprietary naming,” the letter says. “USP works with other stakeholders, nationally and internationally, to accomplish that objective. Divergence from this process in the United States could jeopardize the supply chain and make medications less safe. The current proposal would result in FDA having sole responsibility for establishing non-proprietary names for these medicines, without allowing for adequate stakeholder discussion and input, including through full comment and rulemaking, and would represent a significant departure from the long established public process established by Congress which gave the primary authority to establish all non-proprietary names for all medicines to USP.”

The groups say that the significance of such a change cannot be underestimated. They express concern that any naming approach assigning a unique non-proprietary name to each biological drug, including biosimilars, would create unclear and complex naming conventions that could lead to unintended consequences and barriers to access for biologic and biosimilar medications; result in practitioner and patient confusion and miscommunication relative to the appropriate use, safety, and efficacy of the medications; and impede substitutability of interchangeable products through state policies.

Signing the letter were the Academy of Managed Care Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, Biosimilars Council of the Generic Pharmaceutical Association, International Academy of Compounding Pharmacists, National Alliance of State Pharmacy Associations, National Community Pharmacists Association, and National Council for Prescription Drug Programs.

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