After years-long delay, Novartis' Sandoz finally wins Neulasta biosimilar nod

Back in 2016, FDA stiff-armed Novartis and its biosimilar version of Amgen's Neulasta. After three long years and one batch of new study data, the company finally has its approval and and plans to launch yet this year. 

Dubbed Ziextenzo, the biosimilar won approval to boost white blood cells called neutrophils in cancer patients receiving chemotherapy. As Sandoz president Carol Lynch said in a statement, patients with low neutrophil counts can have "serious consequences," such as dose reductions or outright delays in chemo treatment. 

The Tuesday approval is a turnabout after the FDA rejected the Sandoz drug in July 2016. At the time, Novartis said it was working with the agency to address outstanding questions on its application. It resubmitted the application in April of this year, along with additional data from a pivotal pharmacokinetic study. 

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Now, Sandoz is gearing up for a launch later this year that will bring its biosim count to eight worldwide. The company hasn't disclosed a price, but Amgen faces two other Neulasta biosims—from Mylan and Coherus—at discounts of up to 33% off the brand's sticker. Another entrant will likely mean fiercer competition for Amgen and perhaps even lower prices.

As Coherus geared up for its January 2019 launch, SVP Jim Hassard called its price "attractive to payers without diminishing the value proposition" of its copy, dubbed Undenyca. And besides Undenyca’s price, Coherus saw a market advantage in its patient and reimbursement services, not to mention a solid supply to make sure patients get the drug when they need it. The company’s manufacturing means it has plenty “to enter the broad marketplace,” Hassan said. “And again some competitors that have entered the market maybe haven't had that same luxury.” 

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Mylan launched its own Neulasta biosim, Fulphila, last summer, focusing on community oncology clinics and hospital-based outpatient clinics rather than hospitals themselves, Chief Commercial Officer Tony Mauro said last fall. During its Q3 2018 earnings call, Mylan President Rajiv Malik said its manufacturing "capacity is exactly as we had planned and as we had anticipated" for the launch.

Since those launches, biosim sales have shifted into gear and the competition is already showing up on Amgen’s earnings reports. Sales for the key med slipped 32% in the third quarter to $711 million. Amid the decline, Amgen’s own biosimilars are helping out, growing sales to $173 million during the quarter. 

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Sandoz already markets a short-acting biosimilar version of the drug, Zarxio. In the first nine months of 2019, Novartis reported $1.2 billion in sales for its biopharmaceutical group, which includes biosims, biopharma contract manufacturing and Glatopa, its generic to Teva's multiple sclerosis med Copaxone.