publication date: Feb. 6, 2015

As Biosimilar GCSF Looms Over U.S. Market, Big Players Line Up for Emerging Competition

In the next few weeks, FDA will announce its decision on Novartis’s Zarxio, a granulocyte-colony stimulating factor biosimilar to Amgen’s Neupogen.

If it’s approved—and outside observers uniformly believe it will be—Zarxio will become the first biosimilar agent to enter the U.S. market. Indeed, the FDA Oncologic Drugs Advisory Committee last month unanimously gave it thumbs up.

Being the first, Zarxio will provide a case study in the pricing of these agents.

The question of price is particularly important, because an entire generation of expensive biologics is set to come off patent, and, with the stakes being high, major pharmaceutical companies are vying to enter the biosimilars business.

The most recent example: Pfizer earlier this week entered a definitive merger agreement to acquire Hospira, a major manufacturer of injectable, infused drugs and biosimilars. Pfizer is paying $90 a share in cash in a deal valued at about $17 billion.

“There are significant upfront costs for the biosimilar company related to learning how to make to make this drug, setting up the dedicated facilities to manufacture the drug and getting FDA approval to do so for the U.S. market,” said Rena Conti, an assistant professor at the University of Chicago Department of Pediatrics, in the Section of Hematology/Oncology.

“That entails a series of inspections and fees. After the company builds the dedicated facilities for biosimilar production, FDA approval alone takes 18 months and possibly longer.”

The Cancer Letter asked Conti to analyze the potential … Continue reading 41-05 As Biosimilar GCSF Looms Over U.S. Market, Big Players Line Up for Emerging Competition

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