Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products
May 13, 2019
Arlington, VA – US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.
Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School. Alliance for Safe Biologic Medicines (ASBM) was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”. Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology, nephrology, and ophthalmology. The full survey may be viewed here.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
“US physicians have once again spoken very clearly in support of the FDA and of distinct naming”, said Madelaine Feldman, MD FACR, Chairwoman of ASBM, who conducted the survey.
A minority of parties submitting comments to the FDA during the recent comment period opposed the FDA policy, including health insurance companies, national chain drug stores, and pharmacy benefit managers. Opponents of distinct naming submitted 17 individual comment letters and a joint comment letter with 29 signatories, compared to more than 250 organizations and individuals who wrote in directly or signed letters of support. Still other commenters supported distinct naming, but had comments on the suffix design or implementation. Biologic manufacturers varied widely in their support.
“Biosimilars offer patients increased access to life-changing therapies, at reduced cost for patients and our health system. In order to reap these benefits, physicians and patients need confidence that adverse events will be attributed to the correct product, be it originator or biosimilar. Physicians and patients have spoken clearly to FDA: distinct naming is essential to building that confidence”, said Dr. Feldman.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups including physicians, patients, pharmacists, manufacturers of innovator biologics and biosimilars, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
Media contact: Ray Patnaude [email protected]