September marks the beginning of a busy fall for the Biosimilars Council, beginning with the release of our annual U.S. Generic & Biosimilar Medicines Savings Report—our 14th in collaboration with the IQVIA Institute. This year’s report showed that in 2023, savings from the use of biosimilar medicines reached $12.4 billion. Since their introduction to the market in 2015, biosimilars have generated $36 billion in savings, and have been used in 2.7 billion days of patient therapy, supporting 495 million incremental days of therapy that patients would otherwise not have received.
As you well know, biosimilar medicines significantly reduce costs and increase lifesaving treatment options for patients, and they continue to demonstrate their safety and effectiveness with no meaningful differences in clinical outcomes. Despite progress, biosimilars averaged less than 20 percent of market share in 2023, highlighting the persistent challenges to biosimilar growth and cost-savings. The Council believes that to further expand patient access to care and reduce healthcare spending, policymakers must continue to streamline the U.S. Food and Drug Administration (FDA) approval process, prevent patent thickets, and remove the perverse incentives of brand drug rebates. You can read the full report and key finding for 2023 here.
On the Hill, Congress returns to Washington the week of Sept. 9 with just three weeks to pass government funding that runs out on Sept. 30, before their scheduled adjournment to campaign in October ahead of the November election. Also of note, the House Judiciary Committee will be holding a hearing with PBM executives on Sept. 11, and the Senate Finance Committee is looking to hold a hearing on health provisions included in the Inflation Reduction Act (IRA) on Sept. 18.
On the regulatory side of things, the Biosimilars Council commented last week on the FDA’s June 2024 Draft Guidance Docket No. FDA–2017-D-0154, focused on considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. The Biosimilar Council appreciates and agrees with the FDA’s position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines. The 2024 Draft Guidance is consistent with, and further supported by, the FDA’s position in the April 2024 draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. Taken together, the FDA’s June 2024 and April 2024 Draft Guidance are an important step towards facilitating the approval and acceptance of interchangeable biosimilar products, which can increase patient access to critical therapies and decrease healthcare costs.
Finally, if you have not yet registered for our October 21–23 GRx+Biosims conference, we encourage you to do so. The conference is shaping up to be a great opportunity to hear from policymakers and discuss the scientific, regulatory and policy issues that will shape the future of biosimilars.
