Keytruda Biosimilar Sponsors Await Merck’s Subcutaneous Data

Potential For 2024 Launch Would Protect 2028 Intravenous LOE

20 Dec 2022

With global sales north of $15bn in the first nine months of the year, Merck is desperate to shield its Keytruda for as long as possible, including with a potential subcutaneous formulation.

Subcutaneous injection — Keytruda SC has the potential for major conversion • Source: Shutterstock

With key patents set to lapse at the end of the decade, biosimilar sponsors targeting Merck & Co’s Keytruda (pembrolizumab) intravenous injectable will be watching with a keen eye early in the new year as the originator targets a Phase III readout for a proposed subcutaneous version of its PD-1 inhibitor to treat forms of cancer.

Merck hopes to have Phase III data for a subcutaneous Keytruda formulation available in February 2023, providing a potential bulwark...