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US FDA panel to review Amgen, Allergan's biosimilar for Roche's cancer drug


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US FDA panel to review Amgen, Allergan's biosimilar for Roche's cancer drug

The U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee will review Amgen Inc. and Allergan PLC's biologics license application for ABP 215, a biosimilar candidate to cancer drug Avastin, on July 13.

Amgen and Allergan submitted the application in November 2016, after a phase 3 study in non-squamous non-small cell lung cancer patients confirmed no clinically meaningful difference between the biosimilar and Avastin in efficacy, safety and immunogenicity.

The committee will review data from the drug's studies and the U.S. regulator has set a target action date of Sept. 14.

Roche Holding Ltd.'s Avastin is approved to treat various types of cancers including those of lung, brain and kidney, and booked global sales of CHF6.78 billion in 2016.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars.

The review comes after the U.S. regulator's committee voted to support approval of Pfizer Inc.'s biosimilar of Amgen's Epogen for the same uses the innovator drug is cleared for in the U.S.

The FDA has so far approved only five biosimilars, which includes Amjevita, Amgen's biosimilar version of AbbVie Inc.'s Humira.