Sandoz has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia, challenging what it describes as anticompetitive practices that have prevented patient access to its FDA-approved etanercept biosimilar for nearly a decade.
The litigation, announced on April 14, 2025, aims to accelerate US market access for Erelzi® (etanercept-szzs), Sandoz's biosimilar version of Amgen's blockbuster inflammatory disease treatment Enbrel® (etanercept). Despite receiving FDA approval in 2016, Erelzi® has been unable to enter the US market while being available to patients in Europe since that same year.
Allegations of Anticompetitive Behavior
Sandoz, a global leader in generic and biosimilar medicines, alleges that Amgen has "unlawfully purchased and used certain patent rights to entrench its position in the market" for etanercept, effectively blocking more affordable biosimilar competition. The company claims these actions have artificially extended Amgen's market dominance for Enbrel®, which was first approved by the FDA in 1998 and generated $3.3 billion in US revenue in 2024 alone.
"This case represents a significant barrier to patient access for critical medications," said a Sandoz representative. "Our biosimilar has been approved and available in Europe for years, while US patients continue to face limited options and higher costs."
Impact on Patient Access
The legal action highlights the potential impact on approximately 7.5 million Americans living with chronic inflammatory diseases who could benefit from biosimilar alternatives. These conditions include rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis—all FDA-approved indications for both Enbrel® and Erelzi®.
Biosimilars typically enter the market at prices 15-35% lower than reference biologics, potentially expanding access to patients who struggle with the high cost of these therapies. For inflammatory conditions like rheumatoid arthritis, where annual treatment costs can exceed $50,000 per patient, such savings could significantly impact both individual patients and healthcare systems.
Clinical Evidence and Regulatory Status
Erelzi® underwent comprehensive development and testing before receiving FDA approval. The global development program included analytical and preclinical studies, pharmacokinetic assessments, and the Phase III EGALITY trial, which confirmed the biosimilar's safety and efficacy profile compared to the reference product.
The FDA approved Erelzi® for the same indications as Enbrel®: adult rheumatoid arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and moderate to severe plaque psoriasis.
Legal Remedies Sought
Sandoz is pursuing two primary remedies through this litigation. First, the company seeks an injunction to prevent Amgen from using certain patent rights to block biosimilar competition, which would clear the path for Erelzi® to launch in the US market. Second, Sandoz is seeking damages, which could potentially be tripled under applicable antitrust laws.
The case highlights ongoing tensions in the US biosimilar landscape, where legal challenges and patent strategies have frequently delayed market entry for FDA-approved biosimilars, limiting the cost savings and expanded access these products are designed to provide.
Broader Context of Biosimilar Access
This lawsuit occurs against the backdrop of growing scrutiny of pharmaceutical patent practices and pricing. While the European market has seen robust adoption of biosimilars resulting in significant cost savings, the US has experienced slower uptake partly due to legal and patent barriers.
Sandoz has been at the forefront of biosimilar development globally, having launched the world's first biosimilar in 2006. The company's portfolio includes approximately 1,300 products addressing conditions from common ailments to cancer, with biosimilars representing a key growth area.
Industry analysts note that the outcome of this case could have implications beyond etanercept, potentially influencing how courts view similar patent strategies for other biologic medicines approaching patent expiration.
Market Implications
If successful, Sandoz's legal action could disrupt Amgen's significant revenue stream from Enbrel®. The $3.3 billion in 2024 US sales represents a substantial portion of Amgen's overall revenue, making the defense of this market position a likely priority for the company.
For patients with inflammatory conditions, the introduction of a biosimilar alternative could expand treatment options and potentially improve adherence by reducing out-of-pocket costs. Healthcare systems and insurers would also stand to benefit from the competitive pricing pressure that biosimilar entry typically creates.
The case will be closely watched by other biosimilar developers, reference product manufacturers, and healthcare stakeholders as a potential indicator of how courts may address similar patent disputes affecting biosimilar access in the future.
