Novartis rolls toward FDA nod with a copy of Amgen's Neupogen

Novartis' ($NVS) copy of Amgen's ($AMGN) top-selling Neupogen matched up well with the original, FDA reviewers said, recommending what would be the first U.S. approval of a biologic knock-off.

In briefing documents released ahead of a panel meeting, FDA staff found "no clinically meaningful differences" in the effectiveness of the two injections across all 5 of Neupogen's indications. The treatment, developed as filgrastim, is designed to prevent fever and infections in cancer patients taking chemotherapies that hamper bone marrow activity, bringing in $1.4 billion for Amgen last year.

Now, a panel of FDA advisers will take up the issue on Wednesday, issuing a yes-or-no recommendation that will inform the agency's final decision on Novartis' biosimilar, marketed overseas as Zarzio.

Novartis became the first company to file for a U.S. biosimilar approval under the FDA's newly created pathway when it submitted Zarzio over the summer, putting it at the front of the line to tap the stateside market for cheaper versions of blockbuster biotech treatments. Amgen, for its part, is working to get in the way of any such success, filing a lawsuit in the fall in hopes of blocking Novartis over an alleged violation of the Biologics Price Competition and Innovation Act.

Zarzio is already for sale in the more than 40 countries with in-place biosimilar regulations, and the company's Sandoz generics unit touts it as the top-selling copy of Amgen's drug around the world. Sandoz holds a more than 50% share of the world biosimilars market, according to the company, and its late-stage pipeline includes copies of Humira, Enbrel, Rituxan and Procrit, drugs that pull in tens of billions of dollars each year for their inventors.

Meanwhile, thanks to changing regulations and a looming biotech patent cliff, the global market for biosimilars is poised to boom. According to a report from Allied Marketing Research, worldwide sales for copycat biologicals will reach $35 billion by 2020 after scraping together just $1.3 billion last year, as blockbusters like Humira and Remicade lose exclusivity.

- read the briefing (PDF)