(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has taken important steps to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs.

In early March, the FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), which is used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

That’s a great start, and the FDA is pleased to see the progress. Manufacturers are working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. The FDA is also working hard to help those manufacturers bring more biosimilars to the market.

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