Roche took a blockbuster double hit Thursday as the FDA’s Oncologic Drugs Advisory Committee recommended an Amgen biosimilar to Avastin in the morning, and then a Mylan biosim to Herceptin in the afternoon.
The committee voted 17-0 to recommend FDA approval for Amgen’s ABP 215, an Avastin biosimilar, in each of the approved indications for the reference medication. Those uses include metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.
ODAC also voted 16-0 in favor of Mylan’s proposed Herceptin biosim to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. The agency can't approve the biosim in metastatic gastric cancer until Herceptin's orphan exclusivity in that indication runs out in October, an agency representative told the panel.
Together, the Roche biologics pulled in about $5.6 billion in the U.S. last year. The FDA doesn’t have to follow its panel recommendations, but typically does.
In a statement after the vote, Amgen R&D chief Sean Harper said the recommendation for ABP 215 is an “important milestone” as his company “seeks to expand our biosimilar and oncology portfolios.” Amgen is partnered with Allergan on the Avastin biosim program and three other biologic knockoffs.
In a phase 3 study testing the Amgen candidate in non-small cell lung cancer patients, the biosim demonstrated clinical equivalence to Avastin, plus comparable safety and immunogenicity. Ahead of the vote, FDA reviewers concluded that the “totality of evidence” showed the lung cancer data could be extrapolated into Avastin’s other indications.
Amgen and Allergan are now marching toward an FDA action date of Sept. 14.
Mylan, which is partnered with Biocon on its Herceptin biosim, recently wrapped up a patent dispute with Roche, clearing another hurdle in the path to market for that med. In return for a global license with an undisclosed start date, Mylan dropped two challenges at the U.S. Patent and Trademark Office.
The Mylan biosim is awaiting a Sept. 3 decision date at the FDA, and the drugmaker says its product is in a position to reach the lucrative U.S. market first.