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.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.