FDA Approval Marks Epysqli as Second Soliris Biosimilar

The FDA has approved the Biologics License Application for eculizumab-aagh (Epysqli) as a biosimilar to eculizumab (Soliris), Samsung Bioepis announced in a release.¹

The biosimilar has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. The company noted that the medication is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome.

“The FDA approval of Epysqli as a biosimilar to Soliris marks an important milestone for PNH and aHUS communities since biosimilars have a potential to positively impact patients and health care systems by reducing health care costs and improving access to treatments,” said Christopher Hansung Ko, president and chief executive officer at Samsung Bioepis, in the release.¹

“Our mission has been, and always will be, improving the lives of patients by providing quality-assured, safe and effective biologic medicines, and our work to fulfill this mission is expanding into rare disease areas where patients continue to suffer from limited access to life-enhancing medicines.”

The approval was supported by a totality of evidence from a randomized phase 1, double-blind, 3-arm, parallel group, clinical single trial of healthy volunteers (NCT03722329) and a randomized phase 3, double-blind, multicenter, cross-over study in patients with PNH (NCT04058158). The studies showed pharmacokinetics equivalence and comparable pharmacodynamic safety, tolerability, and immunogenicity profiles between eculizumab-aagh and eculizumab and clinical equivalence in efficacy, safety, pharmacokinetics, and immunogenicity between eculizumab-aagh and eculizumab, respectively.

READ MORE: Amgen Gains FDA Approval for First Interchangeable Biosimilar to Eculizumab

PNH, with an estimated prevalence of 50,000, and aHUS, with an estimated prevalence of 5000, are both classified as rare diseases in the US. Whereas eculizumab is regarded as the standard treatment for the diseases, many patients with PNH don’t receive the recommended dosage of the drug, and a significant portion stop treatment within a year and a half, on average.¹

Hight cost is likely a major factor for treatment nonadherence; some biologic treatments can cost up to $30,000 a year.² Biosimilars, highly similar versions of existing biologics with no significant clinical differences from their reference product, can increase affordability and accessibility associated with these therapies. The approval of eculizumab-aagh offers more treatment options for patients with the rare diseases.

The approval of eculizumab-aagh marks Samsung Biopepis’ 8th biosimilar approved by the FDA and the second biosimilar approved for eculizumab. The first, eculizumab-aeeb, received FDA approval in May 2024.³

Eculizumab-aagh has already been approved for treatment of PNH and aHUS by both the European Commission and Korea's Ministry of Food and Drug Safety.¹

READ MORE: Biosimilars Resource Center

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References

1. FDA approves Samsung Bioepis’ EPYSQLI (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). News release. Samsung Bioepis. July 22, 2024. Accessed July 22, 2024. https://www.globenewswire.com/news-release/2024/07/22/2916428/0/en/FDA-Approves-Samsung-Bioepis-EPYSQLI-eculizumab-aagh-as-a-Biosimilar-to-Soliris-eculizumab.html

2. Chen BK, Yang YT, Bennett CL. Why biologics and biosimilars remain so expensive: Despite two wins for biosimilars, the Supreme Court's recent rulings do not solve fundamental barriers to competition. Drugs. 2018;78(17):1777-1781. doi:10.1007/s40265-018-1009-0

3. FDA approves first interchangeable biosimilar for two rare diseases. News release. FDA. May 28, 2024. Accessed July 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-two-rare-diseases