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BIOSIMILAR APPROVALS

Articles

Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.

Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market

Cameron Santoro is an associate editor for The Center for Biosimilars

Biosimilars offer a promising path to affordable, effective treatment, but barriers remain for underserved communities. This 2-part series explores the potential of biosimilars to improve health equity while addressing the obstacles that currently prevent access.

Part 1: Unlocking the Potential of Biosimilars to Improve Health Equity

Dive into biosimilar regulations in the US! Test your knowledge with our quiz on FDA rules, naming tricks, postmarket safety, and more. Ready for the challenge?

Quiz: The US Biosimilar Regulatory System

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.

BioRationality—FDA’s Guidance on Promotional Labeling

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