Every biotech chief has something to say about overcoming the burdens of long and expensive journeys to bring new drugs to market. To hear Kiran Mazumdar-Shaw, the influential chairman of the India-based biotech Biocon, the solutions could be right under our noses in the form of new technologies. Yet the tough part is applying them.
Headquartered in India, where the cost of development is lower than in the West, Biocon prides itself on "affordable innovation." The company is developing new drugs for diseases such as diabetes and has carved out a spot in the growing market for biosimilars, which are copycat versions of biologics.
In a Wall Street Journal piece, Mazumdar-Shaw argues that nearly 12-year development cycles for new drugs and expensive trials make drug innovation unaffordable. Her commentary comes amid debate in the U.S. about the development requirements for biosimilars, which are complex and impossible to replicate exactly, opening questions about whether a knockoff biologic offers comparable safety and efficacy to the originals.
Analytics provides one way to answer some of the safety and efficacy questions about drugs, Mazumdar-Shaw says in the WSJ piece.
"Look at, say, biosimilars," she says. "So much technology is available. Do you really need extended clinical trials? Isn't enough information available to know these drugs are safe and efficacious?"
The more regulators push expensive clinical studies for biosimilars, the higher development costs are likely to go. That might not sit well with those advocating for affordable drug R&D.
- check out the WSJ piece (sub. req.)
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