AAM, Biosimilars Council oppose FDA biosimilar naming update
In comments submitted Tuesday to the Food and Drug Administration, the Association for Accessible Medicines and its Biosimilars Council urged the FDA to reverse course on its current proposal for the naming of biological products, and rescind the suffix-based naming policy that “acts as a barrier to biosimilars access for America’s patients.”
“The agency’s updated guidance on “Nonproprietary Naming of Biological Products” is misaligned with its own Biosimilars Action Plan and undermines the Administration’s commitment to lowering drug prices for America’s patients,” executive director of the Biosimilars Council and senior vice president of policy & strategic alliances AAM Christine Simmon said. “This kind of misguided policymaking delays and derails the development of biosimilars, and is as much of an obstacle for patient access to biosimilars as patent thickets, rebate traps, misinformation campaigns and other anticompetitive tactics used by some brand biologic manufacturers.”
A letter to FDA commissioner Ned Sharpless signed by 28 patient, consumer, taxpayer, employer, pharmacy, provider, health plan and other groups said, “The FDA’s current system of requiring random suffixes for biosimilars and not for their approved reference products fails to confer any safety benefits and ultimately leads to confusion for patients, prescribers, pharmacists and other healthcare providers. Moreover, this approach creates the perception that there are meaningful differences between FDA-approved biologics and biosimilars, when, in fact, agency approval explicitly indicates they have ‘no clinically meaningful differences.”
The list of signatories includes the American Association for Retired Persons, America's Health Insurance Plans, the American Pharmacists Association, Campaign for Sustainable Rx Pricing, CVS Health, National Business Group on Health, Prevent Cancer Foundation and Rite Aid.
“The agency’s updated guidance on “Nonproprietary Naming of Biological Products” is misaligned with its own Biosimilars Action Plan and undermines the Administration’s commitment to lowering drug prices for America’s patients,” executive director of the Biosimilars Council and senior vice president of policy & strategic alliances AAM Christine Simmon said. “This kind of misguided policymaking delays and derails the development of biosimilars, and is as much of an obstacle for patient access to biosimilars as patent thickets, rebate traps, misinformation campaigns and other anticompetitive tactics used by some brand biologic manufacturers.”
A letter to FDA commissioner Ned Sharpless signed by 28 patient, consumer, taxpayer, employer, pharmacy, provider, health plan and other groups said, “The FDA’s current system of requiring random suffixes for biosimilars and not for their approved reference products fails to confer any safety benefits and ultimately leads to confusion for patients, prescribers, pharmacists and other healthcare providers. Moreover, this approach creates the perception that there are meaningful differences between FDA-approved biologics and biosimilars, when, in fact, agency approval explicitly indicates they have ‘no clinically meaningful differences.”
The list of signatories includes the American Association for Retired Persons, America's Health Insurance Plans, the American Pharmacists Association, Campaign for Sustainable Rx Pricing, CVS Health, National Business Group on Health, Prevent Cancer Foundation and Rite Aid.