Diverse Stakeholder Group Expresses Concern for the Naming of Biological Products

Tuesday May 7, 2019

Today, a diverse stakeholder group of 28 patient, consumer, taxpayer, employer, pharmacy, provider, health plan and other groups submitted a letter expressing concern about FDA policy for the naming of biological products. This policy could harm the development of a robust biosimilars market in the United States, putting access and savings for patients in jeopardy.

Dear Acting Commissioner Sharpless:

As stakeholders that support patient access to affordable medicines and competition in the pharmaceutical marketplace, we applaud the Food and Drug Administration’s (FDA) efforts to foster the development of biosimilar medicines for America’s patients. However, we are concerned that as recently updated, the FDA policy for the naming of biological products could harm the development of a robust biosimilars market in the United States, putting access and savings for patients in jeopardy.

We share the FDA’s commitment to patient safety, and as such, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN), devoid of a suffix. 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.

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About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.

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