WASHINGTON, DC (July 18, 2018): The Council for Affordable Health Coverage (CAHC) – a coalition of employers, insurers, life science companies, PBMs, brokers, agents, patient groups, and physician organizations – responded today to the Food & Drug Administration's (FDA) new released Biosimilars Action Plan.
The document calls for specific administrative steps to incentivize the uptake of biosimilars, including new FDA review tools, such as standardized review templates, creating "information resources and development tools" for sponsors of biosimilar applications, establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB), furnishing updated guidance on biosimilar product labeling, and additional actions to provide better clarity and support for product developers.
In doing so, the plan supports a key goal of CAHC's recent response to the Trump administration's request for information (RFI) following the release of its "American Patients First" prescription drug affordability blueprint.
In the comment letter, CAHC called on the administration to, "Foster a robust market for biosimilars and expand patient access to all biologic products," adding that "access to biosimilars will have a significant impact ... on direct spending for biologic drugs."
CAHC President Joel White released the following statement on FDA's Biosimilars Action Plan:
"Improving pathways for biosimilar development is truly putting 'American patients first.' As we noted in our comment letter to the administration just days ago, biosimilars hold the potential to reduce direct spending on biologic drugs by $54 billion in the next decade alone - but only if we take the steps needed today to spur greater competition and equip product developers and sponsors with the tools for success," said CAHC President Joel White. "CAHC has been a consistent advocate for a more robust biosimilar market and, while we look forward to completing a more comprehensive review of FDA's plan, we believe the actions outlined herein will help realize that goal. We commend Commissioner Gottlieb for his leadership on this bold plan and look forward to our continued work together."