Sandoz Group AG SDZNY SDZXF on Monday filed an antitrust lawsuit in the U.S. against Amgen, Inc. AMGN for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the U.S. Food and Drug Administration (FDA) in 1998.
Etanercept is a biologic medicine used to treat various 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.
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In 2024, Enbrel generated $3.3 billion in revenue in the U.S.
Sandoz received FDA approval for Erelzi in 2016, the same year the company launched the medicine in Europe.
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 U.S. District Court for the Eastern District of Virginia.
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 3 confirmatory safety and efficacy EGALITY study.
The FDA approved Erelzi 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).
In April 2024, Sandoz agreed to resolve all patent disputes relating to the FDA-approved Sandoz denosumab biosimilars with Amgen.
Patent infringement proceedings were initially filed by Amgen in the U.S. Federal District Court for the District of New Jersey in May of 2023.
Amgen claimed that Sandoz infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia and Xgeva.
Under the agreement, Sandoz could enter the U.S. market with a biosimilar version of Prolia and Xgeva on May 31, 2025, or earlier, under certain circumstances if customary acceleration provisions are triggered.
Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti and Wyost, on March 5, 2024.
Jubbonti and Wyost are interchangeable with and approved by the FDA for all indications of reference medicines Prolia and Xgeva.
They have the same dosage form, route of administration, dosing regimen, and presentation as the respective reference medicines.
On Friday, Amgen said that the global Phase 3 DeLLphi-304 trial of Imdelltra (tarlatamab-dlle) met its primary endpoint at a planned interim analysis for small cell lung cancer patients who progressed on or after a single line of platinum-based chemotherapy.
Imdelltra demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to local standard-of-care chemotherapy.
The safety profile for Imdelltra was consistent with its known profile. Detailed data from DeLLphi-304 will be presented at an upcoming medical congress.
Price Action: AMGN stock is up 0.97% at $288.74 at the last check on Friday.
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