April Biosimilars Bulletin: Biosimilars Buzz on Capitol Hill

Thursday May 4, 2023

To our biosimilars advocates,

April was a busy month in the biosimilars realm. Below you’ll find a recap of last month’s top stories, as well as a couple upcoming opportunities for biosimilars on the horizon.

Multiple committees in Congress continue work that could have significant impacts on biosimilar development and adoption. The Senate HELP Committee has scheduled a hearing to examine rebate behavior in the insulin market, followed by a session to consider a range of proposals relating to drug pricing, rebates, as well as biosimilar and generic development. And the Senate Finance Committee has released a legislative framework that could affect pricing, rebating and formulary design.

These are only the latest in Congressional interest in drug pricing and biosimilars and will include discussion of a range of proposals that could impact the biosimilar industry. It’s important that we continue putting pressure on lawmakers to protect and expand biosimilarcompetition and ensure that faulty policies don’t make it into final legislation.

Additionally, please note that May 10 is the deadline for biosimilar manufacturers who believe a reference drug for their biosimilar may be a selected drug for initial price applicability year 2026 and seek to meet the requirements for granting an initial delay request must submit their intention to request a delay to CMS. Read CMS’ memo on the issue here.

In addition to these policy developments, April also saw the release of two reports contributing to the evidence on the value and adoption of biosimilars.

The IQVIA Institute’s report, “Unlocking BiosimilarPotential,” finds that more physicians are beginning to hold positive views on biosimilar medicines. Specifically, it notes that 70% of the surveyed physicians reported positive perceptions of biosimilars. While this report focused on European physicians, it serves as an important lesson for U.S. biosimilars advocates: When we educate physicians about the benefits of biosimilars, uptake and acceptance rise.

In addition, the Health Care Cost Institute issued a report showing insulin prices have decreased as a likely result of biosimilars entering the market. In the first three years that insulin biosimilars were available, we see that average prices began to decrease, despite the fact that only 8% of total days supplied were for biosimilars.

Unlocking Biosimilar Potential

However, longer term effects on average prices will be dependent on the uptake of biosimilars, further emphasizing the importance of the task at hand: highlighting the biosimilarindustry and its myriad benefits for public health.

The increased attention on biosimilars presents an opportunity to showcase the way in which biosimilars expand patient access to care and advance solutions to increase biosimilarcompetition and adoption. As biosimilars advocates, we must continue raising public awareness and support for biosimilars. We appreciate your support of this goal.

Finally, I wanted to share that our GRx+Biosims 2023 conference, which features timely programming related to regulatory science and policy issues facing the biosimilars industry, will be held on October 2-4. Sign up here before May 31 to save $100 on your full pass registration.

Be sure to check your inbox for our next newsletter, and check out our website for regular updates, blogs, resources and advocacy tools.


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October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.