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Path to approval: How biosimilars are developed, approved in the US

10:44 EDT 30 Jun 2017 | Healio

As part of the Biologics Price Competition and Innovation Act of 2009 within the Affordable Care Act, an abbreviated licensure pathway was developed for biologics that are “biosimilar” to or “interchangeable” with FDA-approved reference products, with the goal of increasing competition in the biologics market, reducing costs and expanding patient access to these therapies.While there are key differences between biosimilars and generic drugs, this pathway, although more rigorous, shares similarities with the development pathway for generics, according to Stephen B. Hanauer, MD, AGAF, FACG, the Clifford Joseph Barborka Professor of Medicine in the division of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine.

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