Basel, Switzerland – Sandoz, a global leader in biosimilar and generic medicines, today announced that the US Supreme Court has denied its petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi® (etanercept-szzs) for reference medicine Enbrel®* (etanercept). The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen’s patents.
“We are disappointed the Supreme Court decided not to review our case,” said Keren Haruvi, President of Sandoz US and Head of North America. “Today’s decision means Erelzi, a more affordable biosimilar, will not be available to US patients with autoimmune and inflammatory diseases until 2029; nonetheless we remain committed to providing important treatment options for patients affected by these diseases.”
With the trend towards increased spending on specialty medicines only expected to grow [1], biosimilars play an important role in enabling more patients to access biologic medicines and may offer significant savings for patients, helping to alleviate the overburdened healthcare system [2,3]. Estimates suggest that a biosimilar etanercept could have saved the US healthcare system around USD one billion per year [4].
Sandoz was the first company to receive approval from the US Food and Drug Administration (FDA) for a biosimilar etanercept and the first to launch a biosimilar medicine in the US. Erelzi has been approved in the US for more than four years, since August 2016, however Sandoz has been unable to launch this medicine in the US due to the patent litigation.
About biosimilars
A biosimilar is a successor to a biological medicine (known as the “reference medicine”) for which the patent has expired and exclusivity has been lost. Biosimilars have been shown to have equivalent efficacy and comparable safety and immunogenicity. Therefore, physicians and patients can expect the same clinical outcome.
About Erelzi®
Erelzi is the Sandoz biosimilar of the reference medicine Enbrel®. Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel® at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study. Erelzi is being studied in a real world setting through COMPACT, a global non-interventional study conducted in countries such as Austria, Canada, France, Germany, Italy, Poland, Spain, Switzerland and United Kingdom. Erelzi is approved by the US FDA for the following indications: adult rheumatoid arthritis (RA), ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (PsO).
Erelzi® is a registered trademark of Novartis AG.
Important Safety Information
Please see full Prescribing Information for Erelzi here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf
About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.
Sandoz on social media
LinkedIn: https://www.linkedin.com/company/sandoz/
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal
CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/
References
[1] IQVIA IMS Health and Quintiles. “Biosimilars: Who Saves?”. White Paper. Available at: https://www.iqvia.com/locations/united-states/library/white-papers/biosimilars-who-saves. Accessed on March 29, 2021.
[2] IQVIA Institute for Human Data Science. Medicine use and spending in the US: a review of 2017 and outlook to 2022. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022. Accessed on March 29, 2021.
[3] U.S. Food and Drug Administration. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilar Action Plan [press release]. Available at: . Accessed on March 29, 2021.
[4] Data on file. US Healthcare Impact Biosimilar. Sandoz Inc. March 2021.
Contact:
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Chris Lewis
Sandoz Global Communications
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Sandoz Global Communications
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