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.