Biosimilars Council Submits Comments on Biosimilar Action Plan

The Association for Accessible Medicines (AAM) and the Biosimilars Council (a division of AAM) have submitted comments to the FDA in reference to its Biosimilar Action Plan (BAP). The comment letter was cosigned by entities including America’s Health insurance Plans, Global Healthy Living Foundation, CVS, and Express Scripts, among others.

Read more about the Biosimilar Action Plan.

The BAP, which focuses on increasing biosimilar uptake by lowering the costs of biosimilar development, educating stakeholders to improve confidence in the products, as well as balancing innovation and competition, was largely met with support from industry stakeholders. After the release of the BAP, the FDA requested industry comments on the plan, and convened a public hearing. The recent submission from AAM expands upon the verbal comments that executive director of the Biosimilars Council and senior vice president of policy and strategic alliances for AAM, Christine Simmon, delivered during the hearing.

Specifically, the comments included suggestions such as encouraging the FDA to work closely with sponsors to review biosimilar applications using a case-by-case approach, and, when scientifically appropriate, eliminate unnecessary or duplicative requirements. The comments also requested that the FDA finalize guidance on interchangeability and clarify whether the agency still supports the requirement that innovator biologics and biosimilars should include a suffix in their nonproprietary names.

“Getting biosimilars to patients requires more federal policymakers to build on the important steps the FDA already has taken or will take under the Biosimilars Action Plan,” said Simmon. “As the administration continues to implement its blueprint to lower drug prices for America's patients, FDA is the engine that can drive policymakers to leverage biosimilars opportunities.”

In addition to the comment letter, the Biosimilars Council, together with the American Pharmacists Association, also recently released a resource titled “Biosimilar Basics for Patients.” The document explains to patients what biologics and biosimilars are, and explains that a biosimilar will work in the same way as the originator product. It also describes the US substitution process, or lack thereof, in order to allay any fears about a biosimilar being substituted without a patient's knowledge.