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Amid various woes that forced Novartis to warn profits may disappoint this year, one area was thought to be a bright spot — biosimilars. Its Sandoz unit has been a leader in marketing these lower-priced versions of expensive biologics, but last month hit an unexpected snag.

Buried in its earnings announcement this morning was a brief sentence saying it received some bad news from US regulators. The Food and Drug Administration issued a so-called complete response letter rejecting its bid — for now — to market a biosimilar version of Neulasta, which was a $4.7 billion seller last year for Amgen. The drug is used to help people make white blood cells after receiving chemotherapy.


Novartis provided virtually no information about the FDA decision, other than to tell analysts on a conference call that the situation is “complex.” The disclosure was at the end of a long list of developments that was called “Results from important clinical trials and other highlights.”

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