FDA Video Series Highlights Promise of Biosimilars

The FDA recently released a new 5-part video series highlighting biosimilars and interchangeable products. As part of a larger education and outreach effort, the video series provides an overview of the products and focuses on key concepts about development and approval. To date, the FDA has approved 10 biosimilars.

In the first video of the series, which is posted to the FDA's youtube page, FDA Commissioner Scott Gottlieb, MD, and Leah Christl, PhD, Director of OND Therapeutics Biologics and Biosimilars Staff, CDER, FDA, discuss the promise that biosimilars offer in terms of providing more treatment options, more access to medications that can save lives, and the possibility that market competition can drive down the cost of health care. 

"More and more drugs we see coming onto the market are biological products, and so a lot of the important treatments for cancers, a lot of important treatment for rare diseases or different disorders, are biological products," Dr Gottlieb said in the video. 

The video highlights the FDA's abbreviated pathway to approval for biosimilar products and how it can reduce development costs and time to market, which can continue to open more doors for biosimilars. 

"They're just as safe and effective as their traditional counterparts, and they could provide enormous savings to consumers through product competition," Dr Gottlieb concluded in the video. 

For more information, watch the first video of the series below.



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