Association for Accessible Medicines and its Biosimilars Council comments to the FDA on Pfizer’s Citizen Petition
WASHINGTON, DC (MARCH 6, 2019) — The Association for Accessible Medicines (AAM) and its Biosimilars Council submitted comments in support of Pfizer’s Citizen Petition requesting the Food and Drug Administration (FDA) issue manufacturer guidance to ensure truthful and non-misleading communications concerning the safety and effectiveness of biosimilars, including interchangeable biologics. However, AAM and the Council also believe that additional action is needed beyond guidance to fully address efforts to sow doubt among providers and patients about these new, FDA-approved medicines.
“We applaud FDA’s commitment to coordinate with the Federal Trade Commission (FTC) as stated in the Biosimilars Action Plan to address anticompetitive behavior that interferes with biosimilar development, approval and overall competition in the marketplace,” says Christine Simmon, Executive Director, Biosimilars Council, and Senior Vice President of Policy and Strategic Alliances, AAM. “We believe that such coordination should address misinformation campaigns by manufacturers seeking to thwart competition by creating an atmosphere of apprehension about biosimilars approved by the FDA.”
In addition to coordination with FTC, AAM and the Council urge FDA to expand their current education efforts related to biosimilars and serve as the most credible resource about the facts around biosimilars. This includes making clear that payers, providers and patients can be assured that both interchangeable biosimilars and those without that designation have no clinically meaningful differences from the reference biologic and can be prescribed and utilized upon approval.
“FDA has a critical role to play in ensuring that stakeholders—including patients and their health care providers—are well informed about biosimilars. Such efforts must continue in tandem with the emerging marketplace,” Simmon notes.
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.