Sandoz files antitrust litigation against Amgen regarding patient access to etanercept biosimilar in the US
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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
News Market Reaction 1 Alert
On the day this news was published, SDZNY gained 1.50%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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?
