Novartis' Sandoz has already suffered one FDA rejection for its biosimilar version of Roche's Rituxan, and now that the agency is requesting more data, the company is calling it quits.
Sandoz said Monday it won’t keep trying to win U.S. approval, even after the biosimilar won nods in Europe and several other markets. In a statement, Sandoz's global biosim head Stefan Hendriks said the company believes "the patient and marketplace needs in the US will be satisfied” before Sandoz can generate the data the FDA wants.
“We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia,” Hendricks added.
Instead, Sandoz will focus its biosimilar efforts elsewhere. The company has seven global biosim approvals, including three in the U.S. It has a pending FDA submission on its biosim version of Amgen's white blood cell booster Neulasta.
Meanwhile, Teva and Celltrion are advancing with their Rituxan biosimilar. Last month, an FDA panel unanimously backed the partners' candidate, sending it to the FDA for a final say. If approved, Celltrion’s would be the first Rituxan biosim to secure a U.S. nod.
Under a marketing deal, Teva is set to sell that drug in the U.S. The company is “well positioned” to launch the biosim, according to Brendan O’Grady, Teva's EVP of commercial operations in North America. Roche disclosed in its annual report that some of its Rituxan patent protections begin to expire this year.
Used to treat certain autoimmune diseases and cancers, Rituxan is a key performer for Roche as its top biologics increasingly face global biosimilar competition. Last year in the U.S., Rituxan generated more than $4 billion.