Don't count India out yet in biosimilars race, Quintiles exec says

The globe's largest clinical research organization is looking to India as a source for the next waves of biosimilars as $55 billion worth of biotech drugs face patent expirations.

Quintiles Asia senior medical director Charu Manaktala

Just a couple of months after a Cipla executive pronounced the country slow out of the gate in that sector of pharmaceuticals, a Quintiles ($Q) Asia strategist told the Hindu BusinessLine newspaper she sees companies plunging into biosimilars.

Charu Manaktala, a senior medical director at U.S.-based Quintiles, told the BusinessLine that at the clinical research stage of R&D, she sees innovators and biosimilar makers working hard to capture the market for many disease treatments.

Manaktala counted 160 biosimilars that she knows are in different stages of development to offer alternatives to just the top 6 biologics. She said this was the second wave of opportunity, and looking ahead, she expects a third wave as some of the major biotech drugs reach the end of their patent protection through 2020.

The CRO anticipates India drugmakers going global by forming partnerships and stepping up development and production capabilities. An example of the nation's attraction, she said, was Roche's ($RHHBY) decision to partner with India companies and lower its price for Herceptin (trastuzumab) breast-cancer treatment in order to ward off competition.

Herceptin was one of 7 major drugs she listed as losing patent protection during the next 5 years. The others were: Humira, Enbrel, Tituxan, MabThera, Avastin and Remicade, the 7 together worth $55 billion. Just about every type of pharma is joining in the biosimilar "stampede," Manaktala said.

Back in October, Cipla's Chandru Chawla, head of new ventures, said India had a "fundamental disadvantage" in the biosimilar sector because biotech never caught on very well in India, which instead stuck with developing chemical drugs.

He told Reuters India was far behind in terms of the right knowledge, ecosystem and talent pools. South Korea was the only Asia country competing with Europe and the United States in biosimilars, he said.

Manaktala agreed that South Korea was way out front, and added that Japan drugmakers were also moving heavily into biosimilars.

The Quintiles executive said the biosimilars market is constantly evolving, faster than any other part of the pharmaceuticals market.

India regulators are completing work on new guidelines for biosimilars makers, which are expected to be released soon.

- here's the story from the Hindu BusinessLine
- and one from Reuters