As Biosimilars Close in for Its Blockbusters, Roche Looks to New Agents to Shore Up Sales

In an investor presentation given this week, drug maker Roche, the innovator behind multiple blockbuster drugs now facing competition from biosimilars, gave a look inside its strategy for the future.

The drug maker indicates that, conservatively, it plans to see 60% to 70% erosion for rituximab (Rituxan, MabThera), trastuzumab (Herceptin), and bevacizumab (Avastin) by 2023, leaving a gap of approximately $9.6 billion for the company to fill.

To help offset biosimilar competition for rituximab, Roche says it will rely on sales of its obinutuzumab (for which it is also investigating a new indication in lupus nephritis), venetoclax, the investigational antibody mosunetuzumab, and the investigational MDM2 antagonist idasanutlin.

With its brand-name trastuzumab now facing competition in both the United States and the European union, Roche will rely on sales of pertuzumab, a proposed fixed-dose, subcutaneous trastuzumab and pertuzumab combination; and trastuzumab emtansine, an antibody-drug conjugate. Trastuzumab emtansine and pertuzumab in particular, said Roche will offset biosimilar erosion for trastuzumab as uptake in the adjuvant setting has fueled pertuzumab’s sales growth and as patients with residual disease are increasingly treated with trastuzumab emtansine.

As bevacizumab also faces biosimilar competition, Roche looks to atezolizumab, alectinib, entrectinib, and the investigational ipatasertib.

Ranibizumab (Lucentis) is also the target of oncoming biosimilar competition, and already competes for market share in treating eye disorders with off-label bevacizumab and aflibercept; Roche says that it is looking to faricimab, a proposed bispecific monoclonal antibody, to maintain its share of the macular degeneration market. According to Roche, this therapy, if approved, could reduce the treatment burden associated with current therapies, as it could be dosed at intervals of every 6 months or longer with a port delivery system.

The drug maker said that, while it boasted 10 blockbuster drugs in 2018—including rituximab, trastuzumab, and bevacizumab—it could see as many as 14 blockbusters in 2020, given continued performance of the multiple sclerosis drug ocrelizumab and strong sales of the hemophilia A therapy emicizumab, among others.

In its late-stage pipeline are other drugs with large sales potential, including satralizumab, a proposed monoclonal antibody that targets the interleukin-6 receptor and that offers a novel treatment approach for neuromyelitis optica spectrum disorder, and which could compete with Alexion’s eculizumab in that indication.