Aly Quoted on India’s Biosimilar Regulatory Guidance Process

Intellectual Property Group Co-Leader Imron Aly was quoted on India’s regulatory guidance process for biosimilar approval, challenges to entering the international marketplace, and the differences between the U.S. and India’s approval process. 

Imron noted that India’s technical expertise, vast experience with generics development, and huge density of scientists will help them overcome international challenges. He pointed to Bangalore-based company Biocon, which has launched two biosimilars in the U.S. However, many Indian companies engaged in biosimilar manufacturing have not yet broken into the U.S. market.

“There seems to be eagerness from Europe and South America to develop and expand biosimilars in the United States,” he said. “The litigation cost is just a high burden that [Indian companies] are shying away from for the time being.” Fortunately, Schiff has worked with clients to develop alternative fee arrangements.

A key difference between the U.S. and India’s biosimilar guidance is the lack of an “interchangeability” test, which Imron explained is needed in the United States to allow pharmacists to switch patients from reference products without physician permission. In India, biosimilars can be substituted at the pharmacy level without a physician’s approval.

India approved its first biosimilar in early 2000, long before the European Union (2006) and the United States (2015).

“It's very rapid growth, and a large part of that is because [private] investment in pharmaceuticals research and development in India is very high,” Imron said.

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