“Today’s FDA action to enhance the Purple Book is a boon to those seeking to bring biosimilars to America’s patients. This update creates a single searchable electronic database that identifies each biosimilar and interchangeable biologic with its reference product, increasing transparency for patients, providers, payers, manufacturers and other stakeholders. By increasing the utility of the Purple Book, the agency is helping to close both educational and regulatory gaps that will foster patient access to FDA-approved biosimilars and increase their utilization to lower prescription drug costs.
The Council applauds the FDA’s action and continues to call on policymakers to support legislation that would require all patents for the reference biologic to be listed in the Purple Book. The Biologic Patent Transparency Act (S. 659), a bipartisan bill, sponsored by Sens. Susan Collins and Tim Kaine, would increase market-based competition for biologics by helping biosimilar makers cut through patent thickets that delay biosimilars from coming to the market.
We look forward to providing formal public comments to the docket to inform the next phases of development.”
ATTRIBUTE TO: Christine Simmon, Executive Director
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 22 percent of total drug spending. Additional information is available at www.accessiblemeds.org.