Opinion: Biosimilar approval and adoption in the U.S. needs to be expedited
Creating a robust market for biosimilars in the U.S. will require expanding educational programs for doctors and patients and encouraging good-faith efforts to efficiently and fairly resolve patent disputes.
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 Food and Drug Administration 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
