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Say hello to Roche's worst-case scenario: Teva's Rituxan biosim set to launch in U.S.

Already facing the launch of U.S. biosimilar competitors to two of its oncology blockbusters, Roche is facing a tough road ahead. Now, with a Teva and Celltrion biosim of the third member of its oncology troika ready for shelves, Roche's worst-case scenario has officially arrived.

Teva is set to launch Truxima, its copy of Roche's Rituxan co-marketed with Celltrion, next week as the first in a line of challengers to the oncology med's blockbuster U.S. sales.

Truxima will launch with Rituxan's full oncology label––including indications in non-Hodgkin lymphoma and chronic lymphocytic leukemia––at a 10% discount off Rituxan's wholesale acquisition cost. Truxima will list through primary wholesalers at $845.55 for a 100-milligram vial and $4227.75 for a 500-milligram vial with additional discounts and rebates available.

The FDA approved Truxima in November 2018 as the first Rituxan biosim after initially rejecting the copycat's application, citing concerns about a manufacturing plant in South Korea.

Tom Rainey, Teva's senior vice president of U.S. specialty sales and marketing, said Truxima may be the drugmaker's first biosimilar launch, but his team is well prepared to target physicians right away.

"We believe Teva is perfectly positioned to bring biosims to the market," Rainey said. "We have a branded business on the oncology side that’s been very successful and a generics side of the business––biosimilars kind of fit in the middle."

Rainey said Teva's sales team will target doctors who are well aware of biosims and their benefits, with 96% of doctors on their list having a "high to medium" awareness of biosims and 93% of those having previously prescribed one to patients. Rainey didn't say how narrow a focus Teva would take on oncologists on the whole, but that high bar underscores the boundaries Teva is placing on its doctor marketing, at least at first. Despite those limitations, Rainey believed the drug will be well placed to capitalize on the $3.1 billion market its indications cover.

"Obviously we won’t be able to get all the accounts, so we have to focus," he said.

Rainey was also mum on what level of reimbursement access Truxima has already secured, saying the company is "talking to as many people as possible."

A successful launch for Truxima could spell doom for Rituxan, which is already facing sales erosion abroad as biosim competitors chip away at its market dominance. In the first nine months of the year, Rituxan sales declined 33% in Europe and 46% in Japan as biosim competitors crowded in.

By contrast, U.S. sales of Rituxan were actually up 4% to $3.4 billion in the first nine months of this year. For all of 2018, Rituxan bagged $4.24 billion in U.S. sales.

Of course, Rituxan isn't the only Roche oncology med now facing biosim competition in the U.S.

In July, Amgen and Allergan launched copies of the other two meds in its cancer trifecta—HER2-positive breast cancer med Herceptin and colorectal cancer treatment Avastin—threatening a combined $5.9 billion in U.S. sales. Amgen’s Avastin knockoff, Mvasi, was the first oncology biosimilar approved by the FDA in late 2017, and the agency approved Herceptin biosim Kanjinti in June.

Both drugs launched at a wholesale list price 15% cheaper than their reference biologics, the companies said. For Mvasi, that means a price of $677.40 per 100 milligrams and $2,709.60 per 400-milligram single-dose vial. Kanjinti will hit the market at $3,697.26 per 420-milligram multidose vial. Amgen has already inked exclusive deals with some providers.

The Teva-Celltrion pair is also working on a Herceptin copy––Herzuma–– that's expected to launch late in the first quarter of 2020, alongside competitors from Samsung Bioepis and Pfizer. Amgen and Allergan were the only biosim hopefuls that didn't strike a deal with Roche to delay Herceptin copy launches, giving them a leg up in what should soon be a crowded field.

Nov 7, 2019 


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