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 challenges Amgen's market dominance with Enbrel®, which generated USD 3.3 billion in US revenue in 2024.
The lawsuit alleges that Amgen unlawfully purchased and used patent rights to block competition from Sandoz's biosimilar Erelzi®, which received FDA approval in 2016. Despite approval nearly a decade ago, the biosimilar remains blocked from the US market, affecting approximately 7.5 million Americans living with chronic inflammatory diseases who could benefit from more affordable treatment options.
Sandoz is seeking both an injunction to prevent Amgen from using certain 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 l'accesso al suo biosimilare etanercept. La causa contesta il dominio di mercato di Amgen con Enbrel®, che ha generato 3,3 miliardi di USD di entrate negli Stati Uniti nel 2024.
La causa sostiene che Amgen abbia acquistato e utilizzato illegittimamente diritti di brevetto per bloccare la concorrenza del biosimilare di Sandoz, Erelzi®, che ha ricevuto l'approvazione della FDA nel 2016. Nonostante l'approvazione risalga a quasi un decennio fa, il biosimilare rimane bloccato dal mercato statunitense, influenzando circa 7,5 milioni di americani affetti da malattie infiammatorie croniche che potrebbero beneficiare di opzioni di trattamento più accessibili.
Sandoz sta cercando sia un'ingiunzione per impedire ad Amgen di utilizzare determinati diritti di brevetto per bloccare la concorrenza dei biosimilari, sia danni, che potrebbero essere triplicati secondo le 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 en relación con el acceso a su biosimilar de etanercept. La litigación desafía el dominio de mercado de Amgen con Enbrel®, que generó 3.3 mil millones de USD en ingresos en EE. UU. en 2024.
La demanda alega que Amgen compró y utilizó ilegalmente derechos de patente para bloquear la competencia del biosimilar de Sandoz, Erelzi®, que recibió la aprobación de la FDA en 2016. A pesar de la aprobación hace casi una década, el biosimilar sigue bloqueado en el mercado estadounidense, afectando a aproximadamente 7.5 millones de estadounidenses que viven con enfermedades inflamatorias crónicas y que podrían beneficiarse de opciones de tratamiento más asequibles.
Sandoz busca tanto una orden judicial para evitar que Amgen utilice ciertos derechos de patente para bloquear la competencia de biosimilares, como daños, que podrían ser triplicados según las leyes aplicables.
산도즈 (SIX:SDZ/OTCQX:SDZNY)는 암젠을 상대로 미국 버지니아 동부 지방법원에 자사 에타너셉트 바이오시밀러에 대한 접근과 관련하여 반독점 소송을 제기했습니다. 이번 소송은 암젠이 Enbrel®로 시장에서 차지하는 지배력을 문제 삼고 있으며, 이는 2024년 미국에서 33억 달러의 수익을 올렸습니다.
소송은 암젠이 불법적으로 특허권을 구매하고 사용하여 산도즈의 바이오시밀러인 Erelzi®의 경쟁을 차단했다고 주장하고 있습니다. Erelzi®는 2016년에 FDA 승인을 받았지만, 거의 10년이 지난 지금도 미국 시장에서 차단된 상태이며, 이는 만성 염증 질환으로 고통받는 약 750만 명의 미국인에게 더 저렴한 치료 옵션을 제공할 수 있는 기회를 빼앗고 있습니다.
산도즈는 암젠이 특정 특허권을 사용하여 바이오시밀러 경쟁을 차단하지 못하도록 하는 금지 명령과 손해 배상을 청구하고 있으며, 이는 적용 가능한 법률에 따라 세 배로 증가할 수 있습니다.
Sandoz (SIX:SDZ/OTCQX:SDZNY) a déposé une plainte antitrust contre Amgen devant le tribunal de district des États-Unis pour le district est de la Virginie concernant l'accès à son biosimilaire d'étanercept. Le litige remet en question la domination d'Amgen sur le marché avec Enbrel®, qui a généré 3,3 milliards USD de revenus aux États-Unis en 2024.
La plainte allègue qu'Amgen a illégalement acquis et utilisé des droits de brevet pour bloquer la concurrence du biosimilaire de Sandoz, Erelzi®, qui a reçu l'approbation de la FDA en 2016. Malgré cette approbation datant de près d'une décennie, le biosimilaire reste bloqué sur le marché américain, affectant environ 7,5 millions d'Américains vivant avec des maladies inflammatoires chroniques qui pourraient bénéficier d'options de traitement plus abordables.
Sandoz cherche à obtenir à la fois une injonction pour empêcher Amgen d'utiliser certains 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 Virginia eingereicht, um den Zugang zu seinem Etanercept-Biosimilar zu klären. Die Klage stellt die Marktbeherrschung von Amgen mit Enbrel® in Frage, die 2024 in den USA 3,3 Milliarden USD an Einnahmen generierte.
Die Klage behauptet, dass Amgen rechtswidrig Patentrechte erworben und genutzt hat, um die Konkurrenz durch das Biosimilar von Sandoz, Erelzi®, zu blockieren, das 2016 von der FDA genehmigt wurde. Trotz der Genehmigung vor fast einem Jahrzehnt bleibt das Biosimilar vom US-Markt ausgeschlossen, was etwa 7,5 Millionen Amerikaner betrifft, die an chronisch entzündlichen Erkrankungen leiden und von erschwinglicheren Behandlungsoptionen profitieren könnten.
Sandoz strebt sowohl eine einstweilige Verfügung an, um Amgen daran zu hindern, bestimmte Patentrechte zur Blockierung der Biosimilar-Konkurrenz zu nutzen, als auch Schadensersatz, der gemäß den geltenden Gesetzen verdreifacht werden könnte.
- Potential to unlock access to a major market worth $3.3 billion in annual revenue
- Possibility of receiving triple damages if lawsuit is successful
- Already established presence in European market with Erelzi
- Ongoing inability to enter US market despite FDA approval since 2016
- Legal costs and uncertain timeline associated with antitrust litigation
- Lost revenue opportunity during blocked period
Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules
- 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, the same year the company launched the medicine in Europe. 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 Sandoz's SDZNY antitrust lawsuit against Amgen?
When did Sandoz (SDZNY) receive FDA approval for Erelzi and why hasn't it launched in the US?
What legal remedies is Sandoz (SDZNY) seeking in its 2025 antitrust lawsuit?
How many US patients could benefit from Sandoz's (SDZNY) etanercept biosimilar?
