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FDA Provides New Guidance to Manufacturers on Biosimilars
While the marketing of the first biosimilar to be approved in the US market, Zarxio, has been delayed due to a court order, the FDA is providing guidance to manufacturers to help them effectively navigate the process of product development.
FDA has taken important new steps to continue 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, FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), used to help stimulate growth of white blood cells in patients with cancer and help them fight infection. That’s a great start and we are pleased to see the progress.
Manufacturers are working hard to develop more biosimilars for the US market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. FDA is also working hard to help those manufacturers bring more biosimilars to the market.
Read the complete blog on the FDA website: http://1.usa.gov/1K8o7oG
FDA Approves Pegcetacoplan for Rare Kidney Diseases C3G, Primary IC-MPGN in Patients 12 and Older
July 29th 2025The FDA approved pegcetacoplan (Empaveli; Apellis Pharmaceuticals) as the first treatment for patients 12 years and older with the rare, severe kidney diseases C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
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