FDA Panel Supports Novartis Biosimilar of Etanercept

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.

The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made of living cells, and etanercept.

Etanercept has been approved to treat multiple conditions, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Novartis tested the drug, GP2015, in patients with plaque psoriasis, but if approved by the FDA, it would be approved for all sought conditions.

On Tuesday, the panel voted unanimously in favor of approval for Amgen’s biosimilar version of AbbVie Inc’s arthritis drug adalimumab (Humira).

The FDA is not obliged to follow the advice of its advisory panels, but typically does so.