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No 12 Years Exclusivity In Biologics NDA-To-BLA Switch

This article was originally published in Scrip

Executive Summary

Even though the Biologics Price Competition and Innovation Act (BPCIA) – the law that permitted the FDA to approve biosimilars – has been in place since March 2010, it's taken the agency six years to figure out how to implement the so-called "deemed to be a license" provision, which sets a deadline for regulators to stop approving biologics through certain pathways created under the Food, Drug and Cosmetic Act (FDCA).