AMCP Urges FDA to Issue Final Guidance on Biosimilar Interchangeability Standards and Provide Education on Substituting Interchangeable Products

Alexandria, Va., Sept. 4, 2018 — To increase utilization of biosimilars, the Academy of Managed Care Pharmacy (AMCP) is urging the U.S. Food and Drug Administration (FDA) to issue final guidance on interchangeability standards and develop educational materials that underscore the ability of pharmacists to automatically substitute an interchangeable biologic for its reference product.

“We’re calling on the FDA to expedite guidance on reasonable standards for interchangeability,” said AMCP CEO Susan A. Cantrell, RPh, CAE. “The FDA also should develop and promote educational materials that emphasize an ‘interchangeability’ designation means a biosimilar can automatically be dispensed for a branded reference biologic, and does not require physician consultation with a pharmacist prior to dispensing. These two efforts could significantly prompt utilization of biosimilars, which so far have gained little traction in the U.S.”

AMCP presented these and other suggestions at the FDA’s Sept. 4 public hearing on “Facilitating Price Competition and Innovation in the Biologics Products Marketplace.” AMCP has long been a leading advocate for the widespread adoption and use of lower cost and equally effective biosimilars. A 2017 RAND report estimated that biosimilars would lead to a reduction of $54 billion in direct spending on biologic drugs from 2017 to 2026.

AMCP urged the FDA to partner with stakeholders, such as AMCP, to provide robust education on the safety and effectiveness of biosimilars. AMCP already has established the Biosimilars Resource Center (BRC) to provide education and information on biosimilars to health care providers and other stakeholders in a policy-neutral and non-promotional manner (

In addition, AMCP has taken proactive steps to help provide the evidence that stakeholders — including payers, providers and patients — need in order to make informed decisions on the use of biologics and biosimilars. In 2015, AMCP launched the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), a multi-stakeholder research consortium that monitors the safety and effectiveness of novel biologics and biosimilars. Eighteen founding organizations, including manufacturers, managed care organizations, payers and public representatives, convened the first phase of research by the BBCIC.

“BBCIC leverages the significant scientific investment made by the FDA in the Sentinel Initiative, with access to health care data from approximately 150 million of the 193 million patients in the distributed data network.” Cantrell said. “The BBCIC marshals these resources for the important public health benefit of monitoring the safety and effectiveness of biologics and biosimilars.”