FDA opens the door for a Novartis biosimilar of Amgen's Neupogen

The FDA accepted Novartis' ($NVS) application to sell a knockoff of Amgen's ($AMGN) biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.

Novartis is the first to file for a U.S. biosimilar approval under the FDA's newly created pathway, according to the company, looking to market its take on a treatment for patients with low white blood cell counts that brought in $1.4 billion for Amgen last year. The drug, developed as filgrastim, is designed to prevent fever and infections in cancer patients taking chemotherapies that hamper bone marrow activity.

Novartis' version is on the market as Zarzio in the more than 40 countries that have already codified 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 now it's poised to crack the giant in waiting that is the U.S.

Mark McCamish

"This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S., and we applaud FDA for its progress in making this a reality," Sandoz's injectables chief, Dr. Mark McCamish, said in a statement. "As they've done in Europe and other highly regulated markets around the world, biosimilars are poised to increase U.S. patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system."

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.

And Novartis' Sandoz is positioning itself to maintain the lead. The company's late-stage pipeline includes biosimilars of Humira, Enbrel, Rituxan and Procrit, drugs that pull in tens of billions of dollars each year for their inventors.

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