CRA Insights

Keytruda LoE: A seismic shift for oncology?

October 2024
Pharma production

Immune checkpoint inhibitors (ICIs) have changed the face of oncology treatment since their initial entry in the early 2010s. Driven mostly by the group of PD-1 and PD-L1 molecules, they have resulted in cumulative 2023 global revenues exceeding $45 billion USD. Within the PD-(L)1 class, Keytruda is responsible for over 55% of the total global sales. Its current revenue total makes Keytruda a compelling target for payers and healthcare systems to realize savings upon the loss of exclusivity (LoE) for the product, which is currently set for December 2028 in the US and January 2031 in Europe.

In this article, the author Aaron Everitt examines the current clinical situation underpinning Keytruda’s role in oncology, identifies where it is likely to reach, and evaluates what this could mean for the commercial future of oncology given the upcoming LoE and the expected arrival of biosimilar competition.

In the next article in this series, the author will explore how the upcoming PD-(L)1 LoE could impact combination regimen pricing, an ongoing, problematic issue for industry and healthcare systems globally.

Read more about Keytruda’s role in oncology here