HOLZKIRCHEN, Germany – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the United States District Court of New Jersey ruled against Sandoz in patent litigation concerning the Sandoz biosimilar, Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept). The company will appeal the ruling to the US Court of Appeals for the Federal Circuit, and the parties have agreed to an expedited appeal.
“Sandoz respectfully disagrees with the Court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz U.S. and Head of North America. “Valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its U.S. compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to U.S. patients as soon as possible.”
Sandoz is the first biosimilar company to receive FDA approval for a biosimilar etanercept. Erelzi has been approved for nearly three years, however Sandoz has been unable to launch the medicine due to the ongoing patent litigation from Amgen.
With the trend for increased spending on specialty medicines only expected to grow, biosimilars play an important role in enabling more patients to access biologic medicines and may offer significant savings for patients, helping alleviate the overburdened healthcare system. For example, the successful adoption of biosimilar Zarxio (filgrastim-sndz) into clinical practice saved the US healthcare system approximately USD 500m in less than two years.
“Biologics are life-changing medicines, but can be costly, creating significant disparities in patient access that need to be challenged,” said Dr. Robin Dore, Clinical Professor of Medicine, David Geffen School of Medicine at UCLA. “Biosimilars help increase patient access to these potentially life-saving medicines and real-world experience affirms that switching between a biosimilar and a reference medicine is safe and effective. Biosimilars are one critical way to help enable sustainability of our healthcare system.” Estimates suggest that a biosimilar etanercept could save the US healthcare system around USD 1b a year.
All biosimilars go through an extensive regulatory evaluation and approval process. A ten-year-plus growing body of real-world evidence in highly-regulated markets shows biosimilar adoption greatly increases usage of biologic medicines while delivering matched safety, efficacy and quality profiles.
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars and is well-positioned to lead the industry based on its experience and capabilities in development, manufacturing and commercialization. Sandoz was the first to launch a biosimilar in the US, and Erelzi is one of the company’s three FDA-approved biosimilar medicines.