A few weeks ago, Roche CEO Severin Schwan told reporters at Reuters that he was sleeping much better at night. The pharma giant reported some major progress on three key R&D fronts, including the recent news that Genentech’s blood cancer drug Gazyva had proved significantly better than its aging mainstay Rituxan in treating follicular lymphoma, after an earlier study highlighted a major improvement for progression-free survival in CLL.
Tonight’s sleep, though, may be at least somewhat troubled by a setback in Roche’s plans to get a successor in place to substitute for Rituxan as biosimilars start nearing the marketplace. A combination of Gazyva plus chemo didn’t measure up to Rituxan plus chemo for untreated diffuse large B-cell lymphoma. And that could leave the pharma giant vulnerable on one key front as biosimilars crowd in to claim part of a franchise worth $7.1 billion in 2015.
Less than two months ago, Novartis noted that it had filed its EU application for its biosimilar of Rituxan (MabThera), marking the 6th of 10 copycat filings planned for 2015-2017. And it’s looking for a clean slate of approvals for everything that Rituxan is used for now. Novartis has squared off against its Swiss rival Roche, fielding knockoffs as Roche opts to play defense with new drugs.
In recent days the FDA has pushed two biosimilars through unanimous votes by outside experts, sending a clear message that the first wave of U.S. biosimilars is taking shape. And the agency is happy to extrapolate data from one study to grant an approval for a list of approved indications.
Far less certain, though, will be the last-ditch legal fight left to be decided over patent protection for these drugs.
“Two previous studies showed Gazyva helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening compared to Rituxan, when each was combined with chemotherapy. We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.
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