Roche Holding AG has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab (Rituxan).
A recent research update from Morgan Stanley notes that Roche Holding AG has reached a confidential US patent settlement with Pfizer on the French company’s 8,329,172 patent for brand-name rituximab (Rituxan).
The analysts (one who covers Pfizer and one who covers Roche’s partner Biogen) note that biosimilar competition to Roche’s 3 largest biologics—Rituxan, Herceptin, and Avastin—jeopardizes 36% of Roche profits, but they write that Roche’s strong history of patent defense will continue to forestall biosimilar competition.
They note that Roche has successfully defended 7 patents through the inter partes review process to the US Patent Trial and Appeal Board. The company’s patent estate, consisting of 37 patents, and associated litigation will postpone biosimilars until January 2021, they say.
Late last year, the FDA approved CT-P10, a biosimilar referencing Rituxan, which will be sold under the name Truxima by Celltrion and Teva for oncology indications only—a so-called “skinny label.” Roche retains patent exclusivity on some indications; Morgan Stanly said those patents protect 26% of Rituxan’s sales through July 2020, another 20% of sales to April 2018, and another 14% of sales to November 2029.
Pfizer is also hoping for an FDA approval of PF-05280586, a proposed rituximab biosimilar, in the third quarter of this year.
As Rituxan faces more competition, particularly in Europe, Roche is looking more to emicizumab (Hemlibra) for patients with hemophilia A with or without factor VIII inhibitors; ocrelizumab (Ocrevus), an anti-inflammatory drug that is a so-called “biobetter”of rituximab; and the innovator anti—programmed cell death-ligand 1 biologic atezolizumab (Tecentriq) to drive sales.
Formulary management practices in the United States—for example, should they begin to shift more rapidly in favor of less expensive biosimilars—would affect the outlook for Roche, the reports says.
In addition, plans by the Trump administration to implement reform in Medicare Part B “leads to price risk of 13% of the business franchise.” The administration wants to shift some Part B coverage to Part D as part of its plan to reduce total drug spending.