Novartis clears an FDA hurdle with its pioneering biosimilar of Amgen's Neupogen

A group of FDA advisers unanimously recommended approval for Novartis' ($NVS) knockoff of a blockbuster Amgen ($AMGN) treatment, clearing the way for what would be the first U.S. approval of a copycat biologic medicine.

In a 14-0 vote, the agency's independent Oncologic Drugs Advisory Committee voted in favor of OK'ing Novartis' version of filgrastim, which boosts white blood cell production, in all 5 indications approved for the Amgen original, marketed as Neupogen. The FDA is not required to follow the recommendations of its advisers, though it commonly does, and the agency is expected to make a final decision on Novartis' biosimilar in the coming months.

If the injection wins approval, Novartis would be able to cut in on the roughly $1.4 billion Amgen made on Neupogen last year. And the drug, already marketed as Zarzio by Novartis' Sandoz unit in more than 40 countries, is poised to lead the rush of biosimilars coming to the U.S.

Novartis became the first company to file for a stateside biosimilar approval under the FDA's newly created pathway when it submitted its take on filgrastim over the summer, putting it at the front of the line to tap the U.S. market for cheaper versions of blockbuster biotech treatments. Express Scripts ($ESRX) has said the U.S. healthcare system could save roughly ​$250 billion over the next 10 years thanks to the rise of biosimilars, The New York Times reported this week.

But although FDA approval is widely expected, the bigger question for Zarzio--and all biosimilars--is whether physicians will prescribe them interchangeably with their reference products. The agency isn't taking that into account as it considers whether to approve Novartis' candidate, but the company is pursuing comparative studies with the goal of swaying doctors down the road.

Sandoz, which also makes traditional generics, 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.

Mark McCamish

"We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the U.S.," Sandoz biopharma head Dr. Mark McCamish said in a statement.

On a broader scale, 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 more and more blockbusters come off patent.

Amgen, for its part, is fighting to prolong Neupogen's exclusivity, filing a lawsuit in the fall in hopes of blocking Novartis over an alleged violation of the Biologics Price Competition and Innovation Act.

- read Novartis' statement

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