2022 Saw Continued Approvals, Uptake of Biosimilars

Following the FDA’s March 6, 2015, approval of the first biosimilar in the United States — Zarxio (filgrastim-sndz) from Novartis Pharmaceuticals Corp.’s Sandoz unit — these agents have continued to gain market share, even though not all that have been approved have launched. And while the European Union approved its first biosimilar, Sandoz’s Omnitrope (somatropin), almost a decade earlier on April 12, 2006, the U.S. outpaced the EU in biosimilar approvals in the eight-year post-launch period 40 to 15. Last year continued the trend, with the FDA approving seven new biosimilars. AIS Health, a division of MMIT, asked some industry experts about the agents’ impact over the past year.

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