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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.”


Why the company waited to disclose the letter from the FDA, which was apparently received toward the end of last month, is unclear. Often, drug makers disclose such developments separately and shortly after receipt. A Novartis spokesman declined to comment when asked why the company did not disclose the FDA letter sooner or separately.

Until now, the Sandoz unit has fared well with its biosimilar efforts in the US. Last year, the company had the distinction of winning FDA approval to sell the first such medicine in the country — the Zarxio treatment that is a version of Neupogen, yet another big-selling Amgen drug. And just last week, an FDA advisory panel recommended approval for a biosimilar version of Enbrel, which is also sold by Amgen.


To what extent the rebuff by the FDA will amount to a significant blow remains to be seen. In the long run, the Sandoz unit is expected to become a dominant force in the US as it has in Europe. For now, though, Amgen clearly gains. In a research note, RBC Capital Markets analyst Michael Yee wrote that investors have been too gloomy about competitive threats to Amgen.

In any event, this is yet another sobering setback for Novartis, which is already struggling to overcome generic competition to its Gleevec cancer medication. A key theme in its earnings announcement Tuesday was an overdue decision to invest still more to promote its faltering Entresto heart failure drug. Launched in the US last year, the medicine has failed to gain traction with doctors or payers.

The company plans to invest another $200 million in marketing and sales in hopes of boosting prescriptions. Meanwhile, Novartis has begun signing so-called value-based pricing agreements with payers, which calibrate the cost of the treatment with patient outcomes.