ACR Backs FDA Rule Change on Interchangeable Biosimilars Save

The American College of Rheumatology (ACR) submitted comments to the U.S. Food & Drug Administration (FDA) supporting their recent proposal to update the approval process for biosimilars’ interchangeability status by repealing the requirement for switching studies while also encouraging the FDA to continue monitoring the downstream effects of this policy to ensure transparency for patients and prescribing providers.

The FDA’s draft guidance revises the requirement for switching studies for most biosimilars to achieve interchangeable status. Switching studies are clinical studies designed to evaluate the safety and effectiveness of alternating between a biologic drug and an associated biosimilar to determine if the two medications are “interchangeable.” In its guidance, the FDA notes that biosimilars have generally been found to be safe and effective, with no differences in efficacy, safety, or immunogenicity. Thus, requiring switching studies for biosimilar approval is superfluous, and removing this requirement will help increase access to interchangeable drug products.

“The ACR is dedicated to working with the FDA to ensure that unnecessary barriers are removed from rheumatic patients having access to biosimilars and that the process for switching a patient to a biosimilar is comprehensive and fully transparent to both the prescribing provider and the patient,” noted Deborah Dyett Desir, MD, president of the American College of Rheumatology in the comment letter.

However, the letter also notes that ACR is "very concerned about, and opposed to, mandates from health insurers and pharmacy benefit managers to switch from originator products to biosimilars. As such, all pharmacy-level switching must be fully transparent. The prescribing provider and the patient should be informed in a timely manner when a switch at the pharmacy counter occurs."

Switching medications due to mandates from insurers or pharmacy benefit managers implemented for cost-related reasons with minimal regard for the patient’s well-being must be monitored and discouraged.

“We look forward to serving as a resource and working with the agency and other policymakers to explore changes and improvements needed to ensure patients with rheumatic diseases have better access to high-quality medications," the letter concludes.

Read the ACR's full comment letter to the FDA.