India has been at the front the generic drug race for decades, but when it comes to producing biosimilars the country is trailing behind, according to a recent Reuters' report.
"Biosimilars is a big opportunity," Sujay Shetty, leader of the life sciences practice at PwC India, told the news outlet. "But unlike generics, it is not yet an opportunity (for Indian companies) in the U.S."
Reproducing a biologic is much more difficult than copying a chemical-based drug, because it cannot be replicated exactly, which is in part what is stalling a surge in biosimilars there.
"That also means regulators will be eagle-eyed on quality, posing a challenge to Indian companies, which have been distracted in recent years by manufacturing problems that have led to some drugs being barred from key overseas markets," wrote Reuters.
According to Reuters, only three Indian groups are working on biosimilars with U.S. and European markets in mind.
The interesting thing about this subject is that, according to Reuters, biosimilars have been available since the early 2000s in India. This is much earlier than Europe or the United States.
