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.
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.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.