Cipla sets sights on first-wave gains from rollout of Keytruda Biosimilar

Mumbai: Cipla, which recently entered into an exclusive partnership with Qilu Pharmaceutical to commercialise a biosimilar of cancer drug Keytruda (pembrolizumab), is aiming to make it the first wave of global launches of one of world's highest-grossing medicines that generates more than $30 billion a year for innovator Merck, known as MSD in India.

The patent for pembrolizumab, recommended in more than 40 FDA-approved indications in about 19 cancer types, including skin, lung, breast and colon cancer, will expire around 2029.

"We are expecting to be among the first wave of launches," Achin Gupta, MD & global CEO at Cipla told ET. "Given the size of this franchise and the go-to-market opportunities which are available, we are expecting to capture a significant share of the market.


On the market potential, he said, "even a high single-digit share or bordering on a double-digit share is a very large opportunity in this particular segment. I think that is possible for us."

"It could go up if we are amongst the fewer players and, but in any case, if we are amongst the first wave of launch, we will be able to garner a significant share of that market," he said.

In September, Invagen Pharmaceuticals, a wholly owned unit of Cipla inked a strategic partnership with Qilu for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda, for the US. Towards this, Qilu is tasked with development, regulatory registration and supply of the product while Cipla USA will be responsible for the commercialisation of the asset by leveraging its strong market presence.

Cipla Tuesday reported a 35% year-on-year decline in consolidated net profit at ₹878 crore for the September quarter. Total income from operations fell 2% to ₹7,404 crore amid a decline in North American sales and lower contributions from API and other businesses. Cipla's EBITDA fell 27% to ₹1,388 crore from ₹1,895 crore a year earlier, while operating margin contracted to 18.7% from 25%. However, on a sequential basis, margin expanded 200 basis points, while revenue rose 4% over the June quarter.