Novartis gets U.S. nod for long-delayed Amgen copycat

[November 05, 2019]  By John Miller

ZURICH (Reuters) - Novartis on Tuesday won U.S. approval for its long-delayed version of Amgen's $4 billion seller Neulasta drug, helping the Swiss drugmaker in its uphill battle to sell copies of rivals' blockbusters in the world's top drug market.

Novartis's biosimilar, called Ziextenzo, is aimed at helping cancer patients boost infection-fighting white blood cells during chemotherapy.

Ziextenzo was knocked back in 2016 when the U.S. Food and Drug Administration rejected Novartis's submission. That underscored challenges makers of cheaper copies of blockbuster biological medicines face in the United States, compared to the positive reception they have got in Europe.

The FDA's 2016 rejection allowed Coherus BioSciences and Mylan to beat Novartis to the U.S. market with their own Neulasta copies. Novartis now hopes to launch Ziextenzo this year.

"The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option," Carol Lynch, president of Novartis's Sandoz generics division that makes biosimilars, said in a statement.

Biosimilars are near-copies of brand-name medicines. Because they are biological drugs, they cannot be exactly replicated, but studies show they have the same efficacy for patients as the originals.

Novartis has not said why the FDA blocked its first submission, but resubmitted the application in April.

Ziextenzo's U.S. approval also marks yet another example of drugmakers using the letters "Z" and "X" in drug names to grab attention.

The arrival of Coherus's and Mylan's Neulasta copies, priced initially at discounts of some 33%, has made a dent in Amgen's business: Neulasta sales in the third quarter of 2019 fell 32%, a trend Novartis hopes will accelerate now that it has joined the fray.

Novartis markets eight biosimilars in Europe, including Ziextenso, but so far has just four U.S. approvals, illustrating stark differences in the two markets.

In Europe, biosimilars have made significant headway as governments and insurers switch to them in order to save money.

Progress of the cheaper copies in the United States - despite public outrage over high drug prices - has been much slower as projects face delays from patent lawsuits and regulatory issues, as well as tactics by makers of the originals trying to preserve their market share.

(Reporting by John Miller; Editing by Emelia Sithole-Matarise)

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