Intellectual Property Practice Group Co-Leader Imron Aly was quoted on India’s biosimilar development and regulatory guidelines in the global market.
Most recently revised in 2016, the biosimilar guidelines set by India’s Central Drugs Standard Control Organization and the Department of Biotechnology have enabled manufacturers to bypass phase 3 clinical trials in circumstances where sufficient pharmacodynamic (PD) and pharmacokinetic (PK) data are available, opening the door for faster product approvals. The requirements for safety and efficacy trials can also be waived for such products if PD and PK data are available.
Imron said, “Just having a system in place that defines what tests will be needed is a very critically important distinction” compared to other regions that are slower to detail biosimilar approval pathways.
He added that the guidelines have relieved manufacturers of having to conduct redundant studies, which makes bringing a product to market more achievable.
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