India's ability to copy chemical-based drugs has been the foundation of the country's $15 billion pharmaceuticals industry, but its inability to produce more complex biological drugs at scale means regions like South Korea, the United States and Europe are already well ahead in the race, a report by the Economic Times claims.
The country also faces a quality problem because while it can make "biosimilar" medicines that are close enough to the original product to satisfy regulators, Indian companies have been hit with dozens of bans by international regulators recently because of quality control problems at their plants.
The global biosimilar market is predicted to have sales of $25 billion by 2020, according to a 2014 Thomson Reuters report, the Economic Times said.
"Biosimilars is a big opportunity," Sujay Shetty, leader of the life sciences practice at PwC India, told the Economic Times. "But unlike generics, it is not yet an opportunity (for Indian companies) in the U.S."
The newspaper reported that a few domestic companies have launched biosimilar products for the domestic market, but only three companies--Biocon, Dr Reddy's ($RDY) and Intas--are working with international partners for biosimilars destined for markets in the U.S. and Europe. Biocon has a venture with Mylan ($MYL), the Economic Times reports while Dr. Reddy's is developing biosimilars with Germany's Merck KGaA. Intas is working with Canada's Apotex and may partner with a Swiss drugmaker that it declined to name.
Arun Chandavarkar, the chief executive of Biocon, told the Economic Times that the cost and complexity of developing biosimilars will be a deterrent for many Indian players. "At this time, there can't be too many companies willing to put in that much effort and investment," he said.
Chandru Chawla, head of Cipla's new ventures unit, said in the Economic Times report that India's "fundamental disadvantage" over the United States, Europe and South Korea was that biotechnology never evolved in India to the extent that chemistry did.
- here's the story from the Economic Times