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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
Nine public health organizations
to members of US House and Senate committees citing concerns with FDA’s decision to make changes to a section of the FDA and NIH Workforce Authorities Modernization Act. The organizations, including the American Pharmacists Association (APhA), Academy of Managed Care Pharmacy, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, Biosimilars Council, International Academy of Compounding Pharmacists, National Alliance of State Pharmacy Associations, National Community Pharmacists Association, and National Council for Prescription Drug Programs, signed the letter, which was submitted on August 1, 2016.
The organizations noted concerns about Section 11 of the Act, which may exempt certain biological products from abiding by United States Pharmacopeia standards for quality. The main concerns voiced in the letter are related to issues that may arise from biosimilars with different nonproprietary names than reference products.
“We are concerned that any naming approach which would assign 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,” the letter notes. The authors also indicate that this would impact interchangeability, and potentially create confusion for prescribers and patients. Having separate nonproprietary names for biosimilars may "perpetuate the notion that biosimilars are not comparable to the reference biologic drug," the letter asserts.
Edits to section 11 of the FDA and NIH Workforce Authorities Modernization Act say “except that (1) a product for which a license has been approved under this section shall not be required to have an approved application under section 505 of such Act; and (2) those provisions of the Federal Food, Drug, and Cosmetic Act that refer to an official compendium as defined under section 201(j) of such Act shall not apply to a biological product subject to regulation under this section.” The letter notes USP is currently the primary entity establishing nonproprietary names. These proposals would represent a significant diversion from the established processes that could “jeopardize the supply chain and make medications less safe,” the authors write.
In the letter, the organizations reiterate their concern for standardized naming of biosimilars, requesting FDA to not move forward with the current proposal. “We believe that biologics and biosimilars should be required to have the same nonproprietary names based on existing standards and mechanisms,” the letter states.
This is just the latest in the long debate over biosimilar naming, for which FDA has yet to provide clear guidance. In a Federal Registernotice released in June 2016, FDA said it would require applicants to submit up to 10 proposed four-letter suffixes for biological products licensed under the Public Health Service Act. The agency later withdrew this notice, and has yet to release anything further on the topic. FDA’s draft guidance on Nonproprietary Naming of Biological Products noted that the agency was asking for comment on whether or not a biosimilar name should contain the same suffix as its reference product.