What biosimilar threat? Roche wins another reprieve as FDA stiff-arms Novartis Rituxan copy

Roche's Rituxan just got another biosim break. Rival drugmaker Novartis said late Wednesday its knockoff version didn't pass muster at the FDA.

Cue the relief at Roche, where executives have been bracing for U.S. competition to the company's top drug, which brought in $4.41 billion in the country last year. Analysts had predicted Rituxan would face biosimilars stateside in 2018, but with Novartis knocked aside and another would-be copycat, Celltrion, similarly thwarted, that's looking more and more unlikely.

Indeed, the megablockbuster cancer med could now U.S. dodge competition until next year, Deutsche Bank analyst Tim Race wrote in a note seen by Reuters.

The FDA issued a complete response letter for Novartis' Rituxan biosim, the company reported without detailing the agency's reasoning. Novartis in a statement said it's "disappointed," but maintains it's still committed to advancing the product to market.

First approved in 1997 in the U.S., Rituxan treats follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, as well as rheumatoid arthritis. It's one in a trio of Roche blockbusters threatened by biosims in the next few years.

At 7.38 billion Swiss francs in global 2017 sales—about $7.4 billion—Rituxan had topped the industry's list of biologic meds susceptible to biosimilar rivals in 2018. The company itself acknowledged the treatment could see U.S. biosimilar entrants this year, and it has already suffered from knockoff competition in Europe.

As Race noted, that's changed. And Rituxan isn't the only Roche drug to benefit from rivals' stumbles. Novartis' complete response letter this week follows a Pfizer shortfall on its version of Roche's second-biggest seller, Herceptin. The New York drugmaker said April 23 the FDA wanted "additional technical information" before approving the product.

On a conference call this week, Pfizer chief operating officer Albert Bourla said the rejection was unexpected, but it shouldn't have any effect on the drugmaker's launch timing because the CRL didn't involve questions about safety, efficacy or manufacturing. Pfizer has time to answer the FDA before a launch window legally opens; to defend its breast cancer blockbuster, Roche previously sued Pfizer for infringement on 40 patents.

Meanwhile, as the biosims advance, Roche is working to build up steam behind its new meds. In the first quarter, Rituxan revenues slipped 44% in Europe under a biosim attack. But Ocrevus, Roche's new multiple sclerosis med, is among the "best ever" launches in that field, executives say, pointing to its 479 million Swiss francs ($486 million) in sales for the first quarter, with the majority of that revenue coming from the U.S.

Immuno-oncology med Tecentriq, on the other hand, "stalled" quarter-over-quarter, as characterized by Bernstein analyst Tim Anderson. It generated 139 million francs ($141 million) during the quarter. Roche's drug lags leaders in the field Keytruda and Opdivo, from Merck and Bristol-Myers Squibb, respectively.

The FDA issued a complete response letter for Novartis' Rituxan biosim, the company reported without detailing the agency's reasoning. Novartis in a statement said it's "disappointed," but maintains it's still committed to advancing the product to market.

First approved in 1997 in the U.S., Rituxan treats follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, as well as rheumatoid arthritis. It's one in a trio of Roche blockbusters threatened by biosims in the next few years.

At 7.38 billion Swiss francs in global 2017 sales—about $7.4 billion—Rituxan had topped the industry's list of biologic meds susceptible to biosimilar rivals in 2018. The company itself acknowledged the treatment could see U.S. biosimilar entrants this year, and it has already suffered from knockoff competition in Europe.

As Race noted, that's changed. And Rituxan isn't the only Roche drug to benefit from rivals' stumbles. Novartis' complete response letter this week follows a Pfizer shortfall on its version of Roche's second-biggest seller, Herceptin. The New York drugmaker said April 23 the FDA wanted "additional technical information" before approving the product.

On a conference call this week, Pfizer chief operating officer Albert Bourla said the rejection was unexpected, but it shouldn't have any effect on the drugmaker's launch timing because the CRL didn't involve questions about safety, efficacy or manufacturing. Pfizer has time to answer the FDA before a launch window legally opens; to defend its breast cancer blockbuster, Roche previously sued Pfizer for infringement on 40 patents.

Meanwhile, as the biosims advance, Roche is working to build up steam behind its new meds. In the first quarter, Rituxan revenues slipped 44% in Europe under a biosim attack. But Ocrevus, Roche's new multiple sclerosis med, is among the "best ever" launches in that field, executives say, pointing to its 479 million Swiss francs ($486 million) in sales for the first quarter, with the majority of that revenue coming from the U.S.

Immuno-oncology med Tecentriq, on the other hand, "stalled" quarter-over-quarter, as characterized by Bernstein analyst Tim Anderson. It generated 139 million francs ($141 million) during the quarter. Roche's drug lags leaders in the field Keytruda and Opdivo, from Merck and Bristol-Myers Squibb, respectively.

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