Pharmaceutical sales for Swiss Biopharma firm Roche’s second quarter stood at CHF 9.6bn ($9.9bn), with its top three products Mabthera/Rituxan (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab) contributing a total of CHF 5.3bn. All three top sellers were up 4-5% compared to the same period last year.
But all three monoclonal antibodies are beginning to face competition in Europe and US, Roche’s two largest markets. Just this month, for example, the US Food and Drug Administration (FDA) recommended the approval of Amgen’s Avastin and Mylan’s Herceptin biosimilar, while the European Commission approved Truxima in February: Celltrion’s version of Mabthera.
But during a conference call yesterday to discuss results, CEO Severin Schwan remained confident Roche’s robust portfolio would counter any negative revenue effects posed by biosimilar competition.
“As the portfolio is concerned, it very much reflects our strategy, which is based on innovation, on breakthrough medicines,” he told stakeholders. “We stand now at 16 breakthrough therapy designations by the FDA. This is industry leading and it's this kind of innovation, which will enable us to offset the entry of biosimilars, which we expect increasingly so over the next years.”
He added the firm has begun seeing the first rituximab biosimilars in Europe (from Celltrion and its partners) and expect Herceptin biosimilars to arrive towards the end of this year or early 2018. Samsung Bioepis, Amgen and Mylan are among the firms looking to bring their trastuzumab molecules to Europe.
Daniel O'Day , head of Pharmaceuticals at Roche, reiterated subcutaneous reformulations of Mabthera (known as Rituxan in the US) and Herceptin will extend the lifecycle of these two bestsellers.
“We've got Herceptin subcu[taneous] which is up now to around 50% in the launched countries. And we'll be looking at Herceptin subcu after the success from MabThera subcu as well in the United States.
“So I think we've got a variety of programs that allow us to continue to compete against the biosimilars, the most important was in changing the standard of care, but the convenience associated with subcus is substantial… we think that will give us a benefit.”
Roche’s comments may not be a surprise to the biosimilar community on Twitter who earlier this year placed Roche as the best placed originator biologics maker to defend itself from upcoming competitors.
Roche garnered 39% of the 102 responses to a Twitter poll, while fellow reference drugmakers Amgne, AbbVie and J&J took 27%, 22% and 12% respectively.