Amgen, Allergan step up to challenge Roche's Avastin with FDA biosim filing

Amgen and Allergan have submitted an FDA application for their biosimilar copy of Roche's Avastin.

Another day, another advancement for Roche’s biosimilar challengers—and this time, they’re coming after Avastin.

Tuesday, an Amgen-Allergan team announced it had handed in its application for ABP 215, a knockoff of the Swiss drugmaker’s blockbuster that the team says it believes is the first to reach U.S. regulators.

The duo has based the application in part on a Phase III study of patients with non-squamous non-small cell lung cancer, which turned up no significant differences between the two meds in terms of efficacy, safety and immunogenicity.


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If it successfully gets by regulators, the pair could get a shot at snagging a piece of Avastin’s CHF 6.68 billion ($6.66 billion) 2015 haul. Avastin doesn’t rake in all money through treating NSCLC alone, though: The med boasts 7 indications that its copiers will also want to snag, including those in colorectal, breast and kidney cancer.

Meanwhile, Roche is hoping Avastin can keep up the strong growth it posted last year before competition hits. The key med expanded by 8% in the U.S. last year, the company said in its annual report.

Unfortunately for Roche, Avastin isn’t its only cancer behemoth to inherit a challenger this month. Last week, partners Mylan and Biocon submitted their own FDA application.

Amgen, for one, certainly knows what it’s like to be in Roche’s shoes. The first-ever U.S. biosimilar launch was a Novartis copy of its aged Neupogen, and the Swiss drugmaker has already won FDA approval for its second Amgen copy—a version of anti-TNF giant Enbrel, dubbed Erelzi.  

The Big Biotech has been fighting back, though, with its own biosim portfolio. In September, U.S. regulators greenlighted its copy of Humira, the world's best-selling drug.

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