Patient Groups Call for Patient Safety to be Top Priority for FDA Consideration of Biosimilars

WASHINGTON – February 4, 2016- The House Committee on Energy and Commerce’s Subcommittee on Health today held a hearing to examine U.S. Food and Drug Administration (FDA) implementation of the Biologics Price and Competition and Innovation Act (BPCIA). Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA and Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS) provided testimony. However, no patient groups were asked to provide testimony during the hearing.

“Of all the stakeholders in the biosimilar approval process, patients have the most at risk since they are the people whose lives and bodies will literally depend upon the safety and effectiveness of these new drugs,” said Larry LaMotte, Vice President of Public Policy at the Immune Deficiency Foundation and PBSA member. “Given the importance of this issue to patient safety and the impending actions by the FDA both to develop biosimilar approval standards and consider pending applications it is imperative that Congress ensure that the patient voice is a commanding factor in the FDA’s decisions.”

Among its provisions, the BPCIA calls for the creation of a regulatory pathway for new, safe and effective biosimilar drugs, adding choice and additional treatment options for patient communities. Patient safety must remain the paramount concern in the FDA’s biosimilar approval and regulation process and it is critical that Congress ensures that the FDA addresses patient interests in this process.

“While patient communities are eager for new and affordable treatments, patients with rare and/or chronic diseases are keenly aware of the possible risks associated with biologics and biosimilars, including immunogenicity and the lack of long-term safety data for new treatments,” added LaMotte.

The hearing is especially timely as the FDA is now both developing the standards for approval and monitoring of biosimilars and reviewing and acting on a growing number of biosimilar approval applications. An FDA Advisory Committee will discuss the biologics license application for a proposed biosimilar to an biosimilar to an immunosuppressant biologic used to treat a range of chronic conditions including arthritis, psoriasis, and Crohn’s disease, on February 9, 2016.

About Patients for Biologics Safety & Access

Patients for Biologics Safety & Access is a national coalition representing more than 20 patient advocacy organizations. The goal of the organization is to make sure the voices and interests of patients are heard as the FDA seeks to approve a new category of drugs known as biosimilars. For more information, visit or @BiosimSafety.