Novartis gives up on biosimilar Rituxan in US
- Novartis' Sandoz unit last week said it won't pursue U.S. approval of a biosimilar version of Roche's cancer drug Rituxan, shifting gears after receiving a request from the Food and Drug Administration for more data in May.
- The company says it doesn't believe it can fulfill the FDA request before "the patient and marketplace needs in the U.S. will be satisfied" for biosimilar versions of the treatment.
- An initial application by Sandoz for the Rituxan biosimilar was knocked back in May. Elsewhere, however, the Swiss drugmaker has had more luck, winning approvals in the EU, Japan and Australia, among others.
The announcement removes a potential U.S. challenger for Rituxan, whose sales have dropped by half in Europe since the introduction of biosimilars in that market from Sandoz and the Korean drugmaker Celltrion.
But it also suggests that Novartis doesn't see much opportunity for multiple Rituxan biosimilars in the U.S., where Roche expects competitors to Rituxan to enter in the first half of next year.
With the additional request from the FDA, Novartis might not have been able to make it to market before Celltrion and partner Teva's rival biosimilar, which last month won the backing of an FDA advisory panel for their version.
Novartis' Sandoz unit already had three biosimilars approved in the U.S., compared to seven worldwide. The company now says that its resources will be better spent developing other medicines.
In the U.S., the market for biosimilars remains nascent. While the FDA has cleared more and more of the copycat biologics, most have not yet reached patients due to patent litigation and other hurdles. That's left many top-selling biologic brands without competition even when biosimilars are approved.
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