Despite Headwinds, Biosimilars Market Is Growing in 2024

Alex Brill and Christy Robinson | Commentary

The Food and Drug Administration (FDA) has approved a record number of biosimilars in 2024, and the year is only half over. Eleven biosimilars referencing nine distinct biologics have been approved so far, with three approvals on June 28. (The previous record was ten biosimilars referencing seven biologics in calendar year 2019.) Eylea (aflibercept), Prolia and Xgeva (denosumab), and Soliris (eculizumab) will face competition for the first time while the other approvals stand to increase the degree of competition in markets where biosimilars are already approved.

These developments signal notable progress for both the development and approval of biosimilars in the United States and the depth and breadth of competition among biologic drugs. Table 1 shows the biosimilar products approved in 2024 and the total number of approved biosimilars per molecule. In total, 56 biosimilars have been approved in the United States.

Another promising development that will reduce barriers and foster more robust competition is the FDA’s recent draft guidance to generally eliminate the additional data (switching studies) required for biosimilars to receive an interchangeability designation. As we wrote in March, “While one can debate if the two-tiered approval process was ever a good idea, the clinical experiences and scientific understanding related to biosimilars certainly support this change now.” Removing this hurdle for biosimilar manufacturers to receive an interchangeability designation will speed the availability of competitors to reference biologics that are dispensed by pharmacists because a doctor’s approval would not be needed to substitute a biosimilar. The FDA is currently accepting comments on its draft guidance.

Longer-term risks do remain. As we wrote in April, biosimilar uptake and price discounts vary by market, and it remains to be seen what effect the Medicare drug price negotiations enacted in the Inflation Reduction Act of 2022 (IRA) will have on biosimilar manufacturers’ decisions to pursue certain molecules. The risk posed by the IRA for the biosimilar market is sizeable, as the government’s ability to set prices for reference products could diminish incentives for manufacturers to develop future biosimilars. But the developments in the first half of 2024 are encouraging.