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.