Cipla and Qilu Strike Deal to Challenge Merck's Keytruda Ahead of Patent Cliff

India's Cipla (CIPL) has entered an exclusive licensing agreement with China's Qilu Pharmaceutical to commercialize a biosimilar version of Merck's (MRK) blockbuster cancer drug Keytruda in the United States, positioning both companies to capture market share as the original therapy approaches a pivotal patent expiry.

Under the terms of the deal, Qilu will be responsible for development, regulatory approvals, manufacturing, and supply of QL2107 — its biosimilar candidate designed to replicate Keytruda's safety and efficacy profile at a lower cost. Cipla's US unit will handle commercialization and sales.

Cipla said the agreement advances its strategy to build out an oncology-focused biosimilars portfolio, pairing Qilu's research and manufacturing capabilities with its own established US commercial infrastructure.

The partnership targets one of the pharmaceutical industry's most consequential upcoming patent cliffs. Keytruda, until recently the world's top-selling drug, is approved for use across 20 tumor types and 45 cancer indications. Merck is set to lose patent protection on the therapy in 2028, opening the door to biosimilar competition in a market that generates tens of billions of dollars in annual revenue.