Novartis AG Takes on Amgen With Launch of the First U.S. Biosimilar

Published: Sep 04, 2015

Novartis Takes on Amgen With Launch of the First U.S. Biosimilar
September 3, 2015
By Alex Keown, Breaking News Staff

ZURICH – Novartis AG will launch the first approved biosimilar in the United States after a U.S. court denied Amgen ’s appeals to block sales of the drug, which is a “copycat” version of that company’s blockbuster treatment Neupogen.

By offering Zarxio at a price point 15 percent below Neupogen, Novartis and its biosimilar subsidiary Sandoz, Inc. are looking to take a big chunk of the $1.2 billion the drug raked in last year.

“With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the U.S. by offering a high-quality, more affordable version of this important oncology medicine,” Richard Francis, the global head of Sandoz said in a statement.

Novartis’ Zarxio, which is manufactured by its subsidiary Sandoz, was approved under the biosimilars pathway established by the Biologics Price Competition and Innovation Act. Data has shown Zarxio had “no clinically meaningful differences to the US-licensed reference product,” the company said. During the head-to-head PIONEER study between Zarxio and Neupogen, both products produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17 and 1.20 days for Zarxio and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle 1 was also similar (1.8 days ± 0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study. Neutropenia, the condition both drugs treat, happens when common white blood cells, neutrophils, dip below healthy levels, most commonly due to cancer treatment or advanced HIV/AIDS.

That data was enough for the FDA to issue its historic ruling on biosimilars, a move many insurers have called for to drive down health care costs. Zarxio was approved by the U.S. Food and Drug Administration in March, the first biosimilar in the country. Marketed as Zarzio outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide.

Amgen sought to protect its revenue stream by blocking the sale of Zarxio in the United States. In July a U.S. appeals court ruled that Novartis had to wait until Sept. 2 to launch its biosimilar of Amgen’s.

Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010.

Some see biosimilars as a threat to the profit margin of pharmaceutical companies. Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade, Reuters said. Express Scripts Inc., a manager of drug benefit plans in the U.S., estimated the U.S. could save $250 billion over a 10 year span of 2014 and 2024 if 11 of the likeliest biosimilars reach the market, Reuters said.

A 300 microgram syringe of Zarxio is expected to cost $275.66 and the 480 mcg version is expected to have a wholesale cost of $438.98, Reuters said. Wholesale price points for Neupogen are $324.30 and $516.45 for the same syringe formulations, Reuters said.

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