 "pharma sector, drugs, drugmakers")
The US Food and Drug Administration’s (USFDA)’s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars — lower-priced, near-replicas of complex biologic medicines — could significantly benefit Indian biotech companies.
The new framework proposes cutting back on human clinical trials for certain biosimilars to make biologic therapies more affordable for Americans.
This is expected to provide a major fillip to companies such as Biocon, Dr Reddy’s Laboratories (DRL), and Intas that have heavily invested in this segment.
“This progressive step will accelerate patient access to safe, effective, and affordable biologic therapies for cancer, diabetes, and
