Enbrel Biosimilar Market In Sandoz's Grasp; Will Cost, Litigation Derail It?

11 Jul 2016

• By Donna Young

With the FDA giving an overwhelmingly positive review of Sandoz Inc.'s application for its biosimilar version of Enbrel (etanercept), which is sold in the US by Amgen Inc., the product appears to be headed to the US market – pending a likely blessing from the agency's advisory panel, which is meeting on July 13. But Sandoz must still get past litigation and convince prescribers and patients its etanercept biosimilar provides value over Enbrel.

The FDA has given another warm embrace to a biosimilar application – this time for Novartis AG unit Sandoz Inc.'s version of Amgen Inc.'s Enbrel (etanercept), a tumor necrosis factor blocker that first entered the US market in 1998.

In briefing documents released ahead of a July 13 meeting of the FDA's Arthritis Advisory Committee, regulators declared that Sandoz's...

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