Last week, Roche reported that 2018 global pharmaceutical sales for the period January to September were up 7% to CHF32.7bn ($32.8bn), and up 14% to CHF17.19bn in the US, compared to last year.
According to the firm, strong US sales can be partly attributed to new products, including Ocrevus (ocrelizumab), indicated to treat patients with multiple sclerosis, and HER2-positive breast cancer treatment Perjeta (pertuzumab). Roche also highlighted its blockbuster HER2-positive breast cancer treatment, Herceptin (trastuzumab), as a major factor in the firm’s solid bottom line.
However, Roche is now preparing to face biosimilar competition with a Herceptin alternative expected to launch next year, along with soon-to-be off-patent biologics Avastin (bevacizumab) and MabThera (rituximab) – marketed as Rituxan by Biogen in the US.
“We are aware of competitive intelligence around, [and of] where people stand in terms of their approvals, and also when they may be able to launch,” CEO of Roche Pharmaceuticals, Dan O’Day, told investors.
“I think [MabThera biosimilars launching first half of 2019] is our best estimate…Of course, that has some imprecision to it. It could drift into a little later in the year, a little bit earlier in the year, but that’s our best estimate at this stage,” he added.
Concerning biosimilar versions of Herceptin and Avastin, O’Day told investors Roche is “quite confident” market entry will fall at a later date.
“…we expect at least the first entrant of Herceptin in the second half of the year at this stage,” said O’Day.
Roche trusts that its portfolio, and in particular new product launches, will make up any revenue lost to increasing biosimilar uptake.
“…with the ability to offset around CHF10bn in turnover between now and 2022, and with the success of the new launches, it showed that we could more than offset that,” Roche CEO, Severin Schwan, told investors.
While to date, Mylan and Biocon’s Ogivri is the only biosimilar version of Roche’s Herceptin to receive US Food and Drug Administration (FDA) approval, a number of key biopharmaceutical players are also vying for market share, including Pfizer, Amgen, Celltrion and Teva, and Mylan.
In addition, Novartis subsidiary Sandoz has its eyes set on Rituxan – as do Celltrion and Teva. Amgen is also looking to commercialise an Avastin biosimilar in the US.
European erosion
The same results revealed that in Europe, Roche Pharmaceuticals’ sales had declined 8%, from CHF6.76bn for the first nine months of 2017, to CHF6.6bn for the same period this year.
According to O’Day, this anticipated decline was due, in part, to “erosion from the biosimilars of MabThera and the initial biosimilar erosion of Herceptin.”
The European Commission approved both Celltrion’s MabThera alternative, Truxima, and Samsung Bioepis’ Herceptin biosimilar, Ontruzant, last year. Other Herceptin biosimilars to receive European approval this year include Celltrion’s Herzuma, Amgen’s Kanjinti, and Pfizer’s Trazimera.
