Statement by Christine Simmon, Senior Vice President, Policy and Strategic Alliances, Generic Pharmaceutical Association, Regarding Today's FDA Arthritis Advisory Committee Hearing

WASHINGTON, DC (Feb. 9, 2016) — “The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council commend the Food and Drug Administration (FDA) for hosting today’s Arthritis Advisory Committee Meeting on the infliximab biosimilar, an important step toward advancing science and encouraging more choices for patients who previously would have to rely on costly brand biologic medicines.

The value and impact of biosimilars will hinge on the development of smart policy that promotes access and competition. The Biosimilars Council, the leading voice for biosimilars education and advocacy efforts, is pleased to have the opportunity to inform this newer area of health policy and bring together manufacturers and other experts that continue to play an integral role in expanding patient savings and access by making these vital medicines available in the United States.

Development, production and approval of biosimilar products must be grounded in sound scientific principles. In determining that a biosimilar has ‘no clinically meaningful differences’ from its reference biologic, the Agency relies on the expertise of the same scientists that assess applications for new biological products. Approval by these experts requires the full spectrum of robust and rigorous scientific approaches as determined by FDA. For these reasons, providers, patients and others can be assured of the safety and efficacy of FDA approved biosimilars.

Moreover, a reliance on scientific standards dictates that all products with the same active ingredient should have the same International Nonproprietary Name (INN). This methodology is endorsed by numerous scientific bodies, including the U.S. Pharmacopeial Convention (USP). Alternative approaches could elevate patient safety risk, cause provider confusion and hinder the utilization of biosimilar medicines.

GPhA and Biosimilars Council members look forward to working with members of the supply chain, stakeholders and patients to move our health system closer to the day that biosimilars become widely available, enhancing access and growing health savings for millions of patients and the entire health system.”