Industry Odisha Bureau, Oct 28: Cipla has partnered with China’s Qilu Pharmaceutical to commercialise a Keytruda biosimilar in the US. Keytruda, or pembrolizumab, is a blockbuster cancer treatment made by Merck. The innovator is known as MSD in India. It earns Merck over $30 billion a year, Economic Times reported. Cipla now wants to be among the first biosimilar makers to launch.
Achin Gupta, Cipla’s managing director and global CEO, said it expects a first-wave launch. He said the company aims to capture a significant market share. Still, this is management’s ambition, not a confirmed approval or launch date.
Pembrolizumab is a monoclonal antibody that blocks the PD-1 immune checkpoint. This helps the immune system recognise and attack certain cancer cells. The drug reportedly has over 40 FDA-approved indications across about 19 cancer types. These include lung, skin, breast and colon cancers. Its key patent is expected to expire around 2029. Yet actual launch timing may also depend on litigation, settlements and regulatory approvals.
Biosimilars differ from conventional generics. Biologics are large, complex molecules made in living cells. Copies cannot be exactly identical, unlike small-molecule generics. Developers must prove high similarity through extensive analytical and clinical evidence. That raises cost, time and regulatory risk.
The deal was signed in September through Invagen Pharmaceuticals, Cipla’s wholly owned unit. It covers exclusive licensing and supply of QL2107, Qilu’s Keytruda biosimilar, for the US. Qilu will handle development, regulatory registration and supply. Cipla USA will commercialise the product using its existing American presence. This split lets Cipla avoid building the biologic from scratch. Financial terms of the deal have not been disclosed.
Gupta said even a high single-digit or near double-digit share would be very large. He added the share could rise if fewer players enter. But Keytruda’s current sales do not equal the future biosimilar market. Price discounts, rival entrants and payer contracts could shrink overall revenue. Physician adoption and hospital access will also shape demand. Early entry helps, but it does not guarantee lasting leadership.
The biosimilar push comes as Cipla’s core earnings face pressure. September-quarter consolidated net profit fell 35% year-on-year to ₹878 crore. Revenue from operations slipped 2% to ₹7,404 crore. ET linked this to weaker North American sales and lower API contributions. EBITDA dropped 27% to ₹1,388 crore from ₹1,895 crore. Operating margin narrowed to 18.7% from 25%. Sequentially, however, revenue rose 4% and margin widened 200 basis points.
For Cipla, the biosimilar is a long-term bet, not a near-term earnings fix. It reflects Indian drugmakers’ shift toward complex, higher-value medicines. Lower-priced biosimilars could also ease cancer treatment costs, depending on pricing and access. The real test is whether Cipla can turn early entry into durable US growth.
