Comments of the Association for Accessible Medicines and the Biosimilars Council regarding Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability
The Association for Accessible Medicines (AAM) and its Biosimilars Council appreciates and supports FDA’s continued efforts to foster biosimilar competition in the interest of building a sustainable marketplace for these innovative medicines for America’s patients. However, misguided policymaking such as the updated FDA biologic naming convention plays a significant role in delaying and derailing the development of biosimilars.
AAM and the Council submit these comments to FDA’s updated guidance on Nonproprietary Naming of Biological Products.
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.
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.