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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

European Commission Approves First Aflibercept Biosimilar

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.

In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.

Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

Patient Surveys Provide Insight Into Real-World Adalimumab Biosimilar Use in IBD

Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.

Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing

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