Title: Cheaper Soliris Biosimilars Enter US Market, Offering New Hope for Rare Disease Patients

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The US market has welcomed new, more affordable biosimilars to Soliris® (eculizumab), marking a significant milestone for patients battling rare and life-threatening diseases such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG). These biosimilars promise comparable safety and efficacy to the original biologic but at significantly reduced costs, potentially expanding access to essential treatments.

What Are Soliris Biosimilars?

Soliris® is a monoclonal antibody and anti-C5 complement inhibitor used as a standard of care for several rare diseases that involve abnormal complement system activation leading to severe health issues. Biosimilars are highly similar versions of branded biologics like Soliris but are not identical due to the complexity of biologic medicines produced from living cells. They must demonstrate no clinically meaningful differences in safety, purity, or potency to gain regulatory approval.

Key Players Launching Biosimilars in the US

Amgen's Bkemv®

• Launch Date: March 2025
• FDA Approval: May 2024 for PNH and aHUS
• Pricing: Approximately 10% discount compared to Soliris (list price $6,523 per vial)
• Significance: First interchangeable biosimilar to Soliris in the US, meaning pharmacists can substitute it without prescriber authorization
• Regulatory Background: US launch permitted following a 2020 patent settlement with Alexion, Soliris’ original manufacturer[1][2][4]

Teva and Samsung Bioepis’s EPYSQLI®

• Launch Date: Announced April 2025
• FDA Approval: July 2024 for PNH and aHUS; expanded in November 2024 to include gMG
• Pricing: Offered at a 30% discount to Soliris’s wholesale acquisition cost (WAC)
• Strategic Partnership: Samsung Bioepis handles development, manufacturing, and supply; Teva manages commercialization in the US
• Indications: Treatment of adult patients with PNH, aHUS, and AchR antibody-positive gMG
• Market Impact: Projected to significantly improve affordability and accessibility for underserved communities affected by these rare diseases[3][5]

Why Biosimilars Matter: Impact on Patients and Healthcare

Enhancing Access to Treatment

Rare diseases like PNH and aHUS affect tens of thousands of patients in the US but often come with limited treatment options and high costs. For example, PNH affects about 50,000 people, and aHUS affects around 5,000 patients nationwide. High costs of Soliris have contributed to under-dosing and discontinuation—approximately 70% of PNH patients treated with eculizumab are not dosed according to label, and two-thirds discontinue treatment within 18 months, often due to financial burden[3].

By introducing biosimilars with substantial cost reductions—10% to 30% discounts—patients are more likely to maintain continuous and appropriate therapy, improving long-term outcomes.

Supporting Healthcare Sustainability

Biosimilars are not only beneficial for patients but also play a critical role in reducing healthcare expenses. Their availability promotes competition, which drives prices down, allowing healthcare systems to sustain the provision of lifesaving biologics. This is particularly important for costly biologics treating rare diseases, where treatment can otherwise be prohibitively expensive[3][5].

Understanding the Regulatory Landscape

The approval and market entry of Soliris biosimilars in the US came after complex patent litigations and settlements. Amgen's entry was delayed until March 2025 due to a patent settlement with Alexion, initially reached in 2020, highlighting the intricate balance between innovation protection and market competition[1][4].

The FDA requires biosimilars to meet rigorous standards ensuring no meaningful differences in safety or efficacy compared to the reference product. Some biosimilars, like Amgen’s Bkemv®, have even secured "interchangeable" status, allowing pharmacists to substitute them without consulting the prescribing physician, a significant advantage for broad adoption[1][3].

Key Benefits of New Soliris Biosimilars

| Feature | Amgen’s Bkemv® | Teva & Samsung Bioepis’s EPYSQLI® | Reference Product Soliris® | |-----------------------------|----------------------------------|-----------------------------------------------|------------------------------------------------| | FDA Approval | May 2024 | July 2024 (expanded Nov 2024) | Original biologic | | Indications | PNH, aHUS | PNH, aHUS, gMG | PNH, aHUS, gMG | | Interchangeability | Yes | Under FDA provisional interchangeability review| Not applicable | | Pricing Discount | ~10% below Soliris list price | 30% below Soliris WAC | High list price (~$6,523 per vial) | | Manufacturer/Commercialization | Amgen | Samsung Bioepis (manufacturing), Teva (US commercialization) | Alexion Pharmaceuticals (now part of AstraZeneca) |

What This Means for Patients and Providers

• Patients: More affordable treatment options mean improved adherence and outcomes, reducing disruptions due to cost.
• Healthcare Providers: Increased confidence in prescribing biosimilars given FDA approval and interchangeability.
• Payers: Opportunity to optimize budgets while providing access to effective therapies.
• Pharmacists: Ability to substitute interchangeable biosimilars can streamline dispensing and support cost management.

Looking Ahead: The Future of Biosimilars in Rare Diseases

The arrival of Soliris biosimilars is a landmark event signaling a shift towards greater access and affordability in rare disease treatment. As more biosimilars enter the market, patients stand to benefit from enhanced availability of life-saving biologics.

Further biosimilar developments targeting other costly biologics are expected, potentially transforming treatment landscapes across multiple rare and chronic diseases, enhancing patient care, and driving sustainability in healthcare.

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In summary, the US launch of cheaper Soliris biosimilars by Amgen, Teva, and Samsung Bioepis is a game-changer in rare disease therapeutics. With significant cost savings, FDA approvals, and broad patient indications, these biosimilars promise to expand access, improve treatment adherence, and foster a more sustainable healthcare environment for patients with PNH, aHUS, and gMG.

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Published April 18, 2025