Biosimilar approval and adoption in the U.S. needs to be expedited

Stat News

20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. Biosimilars now have the potential to create substantial savings on complex biologic drugs, but only if we can remove the unnecessary barriers that stall their approval and adoption.

In 2015, our company, Sandoz, a division of Novartis, received FDA approval for the first biosimilar in the U.S. Called Zarxio, it is a biosimilar of Amgen’s Neupogen (filgrastim), which is used to help the body make more infection-fighting white blood cells.

At the time, many in health care hoped this represented the beginning of widespread adoption of biosimilar versions of biologic medicines after their patents expired, creating significant benefits for patients and cost savings for the U.S. health care system.

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Michael Wonder

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Michael Wonder