The FDA accepted Apotex's application to copy an Amgen ($AMGN) blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.
Apotex's treatment is a knockoff of Amgen's filgrastim, marketed as Neupogen, which boosts white blood cell production and is often used in tandem with chemotherapy. The Apotex version, called Grastofil, will now undergo the FDA's standard 10-month review process for biosimilars, which will include a date with the agency's independent advisory committee.
If all goes according to plan for Apotex, Grastofil would likely become the second Neupogen copy on the U.S. market, led by Novartis' ($NVS) Zarxio, which is expected to win approval next month. That drug is poised to cut in on the roughly $1 billion Amgen made on Neupogen last year, becoming the first biosimilar product available in the states ahead of a looming patent cliff for biotech blockbusters.
Novartis became the first company to file for a stateside biosimilar approval under the FDA's newly created pathway when it submitted its version of filgrastim over the summer, followed by Celltrion and its copy of Johnson & Johnson's ($JNJ) Remicade. Hospira ($HSP), soon to be a subsidiary of Pfizer ($PFE), is working with Pfenex ($PFNX) on a knockoff of Roche's ($RHHBY) blockbuster eye drug Lucentis, and Novartis' Sandoz, a global leader, is working up copies of Humira, Enbrel, Rituxan and Procrit.
Apotex is also awaiting word on a biosimilar of Amgen's Neulasta, a longer-lasting version of filgrastim. Apotex filed its take on that treatment last year, hoping snag a share of its roughly $3.6 billion in annual sales.
According to a report from Allied Marketing Research, worldwide sales for copycat biologics will reach $35 billion by 2020 after scraping together just $1.3 billion last year, as more and more blockbusters lose exclusivity. And Express Scripts ($ESRX) has said the U.S. healthcare system could save roughly $250 billion over the next 10 years thanks to the rise of biosimilars, but bearish analysts caution there's no guarantee physicians will prescribe them interchangeably with their reference products.
|Apotex CEO Jeremy Desai|
As for Apotex, the company is "dedicated to playing a leading role in the effort to increase the American public's access to more affordable versions of these life-saving therapies," CEO Jeremy Desai said in a statement.
But Apotex will first need to get through the FDA, which has a long history of doggedly chastising the company for its quality control. Apotex has received numerous agency warning letters tied to its operations in India and Canada, including accusations of data manipulation and improper microbial testing, and face a two-year import ban tied to similar problems.
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