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U.S. is closer to first biosimilar

FDA officials see no difference between Neupogen and the biosimilar version.

Earlier this week documents from FDA reviewers decided that there are "no clinically meaningful difference" between Amgen's Neupogen, and Sandoz's biosimilar version, the Wall Street Journal reported.

Neupogen is used during chemotherapy to fight off infections.

According to the article, an FDA advisory committee is expected to be meeting Jan. 7, to review a marketing application filed for the drug.

Their decision could be market-changing.

"If approved, the Sandoz version would become the first biosimilar in the U.S., by way of a regulatory pathway that was created for these medicines three years ago," according to the article.

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