[Corrected] Sandoz files antitrust litigation against Amgen regarding patient access to etanercept biosimilar in the US
Sandoz (SIX:SDZ/OTCQX:SDZNY) has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia regarding access to its etanercept biosimilar. The litigation alleges that Amgen has unlawfully blocked competition by purchasing and using certain patent rights to maintain market dominance for Enbrel®, which generated USD 3.3 billion in US revenue in 2024.
Despite receiving FDA approval in 2016 for Erelzi® (etanercept-szzs), Sandoz has been unable to launch this biosimilar treatment. The medication could potentially benefit approximately 7.5 million Americans living with chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, and other conditions.
Sandoz is seeking both an injunction to prevent Amgen from using patent rights to block biosimilar competition and damages, which could be tripled under applicable laws.
Sandoz (SIX:SDZ/OTCQX:SDZNY) ha intentato una causa antitrust contro Amgen presso il Tribunale Distrettuale degli Stati Uniti per il Distretto Orientale della Virginia riguardo all'accesso al suo biosimilare di etanercept. Il contenzioso sostiene che Amgen ha bloccato illegalmente la concorrenza acquistando e utilizzando determinati diritti di brevetto per mantenere il dominio di mercato di Enbrel®, che ha generato 3,3 miliardi di dollari di entrate negli Stati Uniti nel 2024.
Nonostante abbia ricevuto l'approvazione della FDA nel 2016 per Erelzi® (etanercept-szzs), Sandoz non è stata in grado di lanciare questo trattamento biosimilare. Il farmaco potrebbe potenzialmente beneficiare circa 7,5 milioni di americani affetti da malattie infiammatorie croniche, tra cui artrite reumatoide, psoriasi e altre condizioni.
Sandoz sta cercando sia un'ingiunzione per impedire ad Amgen di utilizzare i diritti di brevetto per bloccare la concorrenza dei biosimilari sia danni, che potrebbero essere triplicati ai sensi delle leggi applicabili.
Sandoz (SIX:SDZ/OTCQX:SDZNY) ha presentado una demanda antimonopolio contra Amgen en el Tribunal de Distrito de EE. UU. para el Distrito Este de Virginia sobre el acceso a su biosimilar de etanercept. La litigación alega que Amgen ha bloqueado ilegalmente la competencia al comprar y utilizar ciertos derechos de patente para mantener el dominio del mercado de Enbrel®, que generó 3.3 mil millones de dólares en ingresos en EE. UU. en 2024.
A pesar de haber recibido la aprobación de la FDA en 2016 para Erelzi® (etanercept-szzs), Sandoz no ha podido lanzar este tratamiento biosimilar. El medicamento podría beneficiar potencialmente a aproximadamente 7.5 millones de estadounidenses que viven con enfermedades inflamatorias crónicas, incluyendo artritis reumatoide, psoriasis y otras condiciones.
Sandoz busca tanto una orden judicial para evitar que Amgen utilice los derechos de patente para bloquear la competencia de biosimilares como daños, que podrían triplicarse bajo las leyes aplicables.
산도즈 (SIX:SDZ/OTCQX:SDZNY)는 버지니아 동부 지방법원에서 암젠을 상대로 에타너셉트 바이오시밀러에 대한 접근과 관련하여 반독점 소송을 제기했습니다. 이 소송은 암젠이 특정 특허권을 구매하고 사용하여 Enbrel®의 시장 지배력을 유지하기 위해 불법적으로 경쟁을 차단했다고 주장합니다. Enbrel®은 2024년에 미국에서 33억 달러의 수익을 올렸습니다.
산도즈는 2016년에 Erelzi® (etanercept-szzs)에 대해 FDA 승인을 받았음에도 불구하고 이 바이오시밀러 치료제를 출시할 수 없었습니다. 이 약물은 류마티스 관절염, 건선 및 기타 질환을 앓고 있는 약 750만 미국인에게 잠재적으로 도움이 될 수 있습니다.
산도즈는 암젠이 바이오시밀러 경쟁을 차단하기 위해 특허권을 사용하는 것을 막기 위한 금지명령과 손해배상을 요구하고 있으며, 이는 관련 법률에 따라 세 배로 증가할 수 있습니다.
Sandoz (SIX:SDZ/OTCQX:SDZNY) a déposé une plainte antitrust contre Amgen auprès du tribunal de district des États-Unis pour le district est de la Virginie concernant l'accès à son biosimilaire d'étanercept. Le litige allègue qu'Amgen a illégalement bloqué la concurrence en achetant et en utilisant certains droits de brevet pour maintenir sa domination sur le marché d'Enbrel®, qui a généré 3,3 milliards de dollars de revenus aux États-Unis en 2024.
Bien qu'ayant reçu l'approbation de la FDA en 2016 pour Erelzi® (etanercept-szzs), Sandoz n'a pas pu lancer ce traitement biosimilaire. Ce médicament pourrait potentiellement bénéficier à environ 7,5 millions d'Américains vivant avec des maladies inflammatoires chroniques, y compris l'arthrite rhumatoïde, le psoriasis et d'autres conditions.
Sandoz cherche à obtenir à la fois une injonction pour empêcher Amgen d'utiliser les droits de brevet pour bloquer la concurrence des biosimilaires et des dommages-intérêts, qui pourraient être triplés en vertu des lois applicables.
Sandoz (SIX:SDZ/OTCQX:SDZNY) hat eine Antitrust-Klage gegen Amgen beim US-Bezirksgericht für den östlichen Distrikt von Virginia eingereicht, die den Zugang zu seinem Etanercept-Biosimilar betrifft. Die Klage behauptet, dass Amgen illegal den Wettbewerb blockiert hat, indem es bestimmte Patentrechte erworben und genutzt hat, um die Marktbeherrschung von Enbrel® aufrechtzuerhalten, das im Jahr 2024 einen Umsatz von 3,3 Milliarden US-Dollar in den USA erzielt hat.
Trotz der FDA-Zulassung im Jahr 2016 für Erelzi® (etanercept-szzs) konnte Sandoz diese Biosimilar-Behandlung nicht auf den Markt bringen. Das Medikament könnte potenziell etwa 7,5 Millionen Amerikanern mit chronisch entzündlichen Erkrankungen, einschließlich rheumatoider Arthritis, Psoriasis und anderen Erkrankungen, zugutekommen.
Sandoz strebt sowohl eine einstweilige Verfügung an, um zu verhindern, dass Amgen Patentrechte nutzt, um die Biosimilar-Konkurrenz zu blockieren, als auch Schadensersatz, der gemäß den geltenden Gesetzen verdreifacht werden könnte.
- Potential to capture share of $3.3B US market upon successful litigation
- FDA approval already secured for Erelzi® biosimilar
- Possible triple damages award if lawsuit succeeds
- Ongoing market entry barriers despite FDA approval since 2016
- Legal costs and uncertain timeline for lawsuit resolution
- Current inability to generate revenue from FDA-approved product
Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules – corrected: reference to date of product launch in Europe removed; link to “Important Safety Information” updated
- Company aims to accelerate access to much-needed biosimilar to reference medicine Enbrel®* for US patients with disabling inflammatory diseases
- Despite FDA approval nearly a decade ago, etanercept biosimilar continues to be blocked
- Sandoz seeking damages in addition to clearing path for launch
Basel, April 14, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel® (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998.
Etanercept is a biologic medicine used to treat a range of disabling inflammatory diseases. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®+ (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. In 2024, Enbrel® generated USD 3.3 billion in revenue in the US[1].
Sandoz received US FDA approval for Erelzi® in 2016. Today, Amgen is continuing to block entry of this important treatment option for approximately 7.5 million Americans living with chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis[2-6], many of whom could benefit from the cost savings and expanded access resulting from the introduction of high-quality, more-affordable biosimilar options.
Sandoz is seeking an injunction to prevent Amgen from using certain patent rights to block biosimilar competition and allow Sandoz to launch Erelzi® as soon as possible. The company is also seeking damages, which could be tripled under applicable laws. The lawsuit was filed in the US District Court for the Eastern District of Virginia.
*Enbrel® is a registered trademark of Amgen, Inc.
+Erelzi® is a registered trademark of Sandoz Inc.
About Erelzi® (etanercept-szzs)
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 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).
IMPORTANT SAFETY INFORMATION
Please see full Prescribing Information for Erelzi® here.
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.
REFERENCES
1. Statista. Revenue of Amgen’s Enbrel by Region from 2011-2014. Available at: Revenue Enbrel worldwide by region 2024 | Statista [Last accessed: March 2025]
2. Xu Y, Wu Q. Prevalence Trend and Disparities in Rheumatoid Arthritis among US Adults, 2005-2018. J Clin Med. 2021;10(15):3289. Available at:
https://pmc.ncbi.nlm.nih.gov/articles/PMC8348893/ [Last accessed: March 2025]
3. Johns Hopkins Arthritis Center. Ankylosing Spondylitis. Available at: https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/ [Last accessed: March 2025]
4. About Juvenile Idiopathic Arthritis. Available at: https://www.arthritis.org/getmedia/6398ed64-029b-4629-82e7-bf91fa61d8f5/Juvenile-Idiopathic-Arthritis-JIA-FactSheet-101122.pdf [Last accessed: March 2025]
5. National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/psoriasis-statistics [Last accessed: March 2025]
6. Weiss PF. Polyarticular juvenile idiopathic arthritis: Clinical manifestations, diagnosis, and complications. Available at: https://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritis-clinical-manifestations-diagnosis-and-complications [Last accessed: March 2025]
CONTACTS
| Global Media Relations contacts | Investor Relations contacts |
| Global.MediaRelations@sandoz.com | Investor.Relations@sandoz.com |
| Alex Kalomparis +41 792 790285 | Craig Marks +44 781 8 94 2383 |
| Joerg E. Allgaeuer +49 171 838 4838 | Rupreet Sandhu +41 791 05472 |
| US Media Relations contacts | |
| Media.Info@sandoz.com | |
| Vicki Crafton +1 201 213 6338 |
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FAQ
What is the potential market impact of SDZNY's antitrust lawsuit against Amgen?
Why hasn't SDZNY's Erelzi® entered the US market despite FDA approval in 2016?
What remedies is SDZNY seeking in its 2025 antitrust lawsuit?
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