(Carmen Segovia) 

Charting Her Own Course

I’ve enjoyed the scientific journey very much,” says Kiran Mazumdar-Shaw. “Both R&D and the creative, innovative aspects of business have given me the motivation to keep on doing it. It’s challenging all right, but very exciting.”

Today, Mazumdar-Shaw’s company, Biocon, employs 5,000-plus people, including some 2,000 scientists, 500 at Biocon itself and the rest at subsidiaries. The firm has operations in Germany and Abu Dhabi as well as in India. Its statin APIs—active pharmaceutical ingredients—and insulin analogs are sold across the globe. In addition, Biocon spends 8 to 9 percent of its revenues on R&D, putting it among the top ten R&D spenders in India.

“We’ve had a culture of research right from day one. As an enzymes company we had to develop all the products ourselves,” Mazumdar-Shaw explains, referring to Biocon’s origins in 1978 as a joint venture with Irish firm Biocon Biochemicals to produce enzymes for the brewing industry.

In the early 1990s, she embarked on her first venture in the field of pharmaceutical research services. “India was beginning to do very well in software services, and I sensed that there was an opportunity in biology,” she says. “The pharma world was engaging in contract research in many, many ways.” This observation heralded the beginning of the end for the enzymes business, although it wasn’t until 2007 that Biocon fully divested itself of enzyme manufacturing.

Today, Biocon focuses on diabetes, cancer and autoimmune diseases and is intent on reducing therapy costs in chronic disease with generics and biosimilars. “We look to partnering as a way to have global access,” Mazumdar-Shaw says. “We are developing a very nice research pipeline, leveraging the cost and clinical base that we have in India.”

Much of Biocon’s revenue to date has come from its statins and immunosuppressants as generic APIs. This small-molecule portfolio will expand in the coming years, but it is the company’s large-molecule portfolio that is particularly intriguing. “Biopharmaceuticals were completely alien [to the sector in India] when we started,” laughs Mazumdar-Shaw. “Most companies were into generic small molecules, and that by chemical synthesis.” Utilizing proprietary technology, Biocon began to make insulin and insulin analogs in the mid-to-late 1990s. “That was a big differentiator,” she says. “No one else in the world was making insulin using this particular technology. So we had both IP and the cost-competitive advantage.” The company is currently working with Pfizer to commercialize its insulin product portfolio and also has an oral insulin product in Phase 3 trials.

“Over time, I started taking slightly bigger bets. I said, let’s look at getting some high-end biotech products like monoclonal antibodies,” she recalls. A visit to Cuba generated a partnership to develop BIOMAb-EGFR, which is an anti-EGFR antibody that was the first novel product of its kind developed in India. “They showed me some clinical data and we decided to develop it,” she explains. BIOMAb-EGFR treats head and neck cancers, brain tumors and other solid tumors. It is available in China, parts of Latin America and India, and is currently undergoing trials in the U.S. and EU.

The company also has an immunomodulating monoclonal antibody in Phase 3 trials for psoriasis, rheumatoid arthritis and multiple sclerosis. “We have global rights and it’s our intention to develop it for global markets,” Mazumdar-Shaw says.

Among Biocon’s other initiatives is a biosimilar antibodies program, being developed in partnership with Mylan. “We have chosen to straddle biosimilars and novel programs as a risk-balanced strategy,” she explains. “The novel programs have the potential of giving us pretty large upsides, if successful.”

Indeed, Mazumdar-Shaw does not fear taking chances. “I allowed people to fail and make mistakes and learn from them,” she says. “We’ve been pioneering, charting our own course.”