• Samsung Bioepis’ eighth biosimilar approved by the U.S. Food and Drug Administration
• EPYSQLI is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
• Approval paves way for expanded access to quality-assured biologics for patients suffering from rare diseases
INCHEON, Korea I July 22, 2024 I Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for EPYSQLI® (eculizumab-aagh) as a biosimilar to Soliris1 (eculizumab). EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
The FDA’s approval of EPYSQLI is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between EPYSQLI and Soliris in terms of safety, purity and potency: The randomized Phase I, double-blind, three-arm, parallel group, single-dose study in healthy volunteers (NCT03722329) demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, tolerability, and immunogenicity profiles between EPYSQLI and Soliris. The randomized Phase 3, double-blind, multicenter, cross-over study in PNH patients (NCT04058158) demonstrated clinical equivalence in efficacy, safety, PK, and immunogenicity between EPYSQLI and Soliris.
“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 healthcare systems by reducing healthcare costs and improving access to treatments,” said Christopher Hansung Ko, President and Chief Executive Officer at Samsung Bioepis. “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,” he added.
The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard treatment for PNH and aHUS, rare diseases with an estimated US prevalence of approximately 50,000 and 5,000 respectively.2,3 Approximately 70% of eculizumab-treated PNH patients are not dosed according to the label, and two-thirds of patients discontinue eculizumab within an average of 1.5 years, which may be attributed to several factors including the high treatment cost.4 Biosimilars, biologic medicines that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biologic, have the potential to relieve the financial burden of the healthcare system and improve access to biologic therapies.5 Biosimilar drugs must meet the same standards for pharmaceutical quality, safety and efficacy as reference products.
Outside of the US, EPYSQLI has also been approved by the European Commission (EC) and Korea’s Ministry of Food and Drug Safety (MFDS) as a biosimilar to Soliris for the treatment of patients with PNH and aHUS. In countries where EPYSQLI is approved and available, EPYSQLI may not be prescribed and/or dispensed for other indications for which Soliris is approved.
About EPYSQLI® (eculizumab-aagh) injection, for intravenous use
EPYSQLI is a complement inhibitor indicated for the treatment of patients with:
• paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
• atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
Limitation of Use: EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Please see the accompanying full Prescribing Information and Medication Guide for EPYSQLI, including BOXED WARNING regarding serious and life-threatening meningococcal infections.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.
1 Soliris is a trademark of Alexion Pharmaceuticals, Inc.
2 National Center for Advancing Translational Sciences. Paroxysmal nocturnal hemoglobinuria. https://rarediseases.info.nih.gov/diseases/7337/index
3 National Center for Advancing Translational Sciences. Atypical hemolytic uremic syndrome. https://rarediseases.info.nih.gov/diseases/8702/atypical-hemolytic-uremic-syndrome
4 Jun Ho Jang, Roberta Demichelis Gomez, Horia Bumbea, Larysa Nogaieva, Lily Lee Lee Wong, Soo Min Lim, Younsoo Kim, Jihye Park. A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria. https://doi.org/10.1002/jha2.632 Volume 4, 2022.
5 U.S. Food and Drug Administration. Biosimilars. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
SOURCE: Samsung Bioepis
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• Samsung Bioepis’ eighth biosimilar approved by the U.S. Food and Drug Administration
• EPYSQLI is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
• Approval paves way for expanded access to quality-assured biologics for patients suffering from rare diseases
INCHEON, Korea I July 22, 2024 I Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for EPYSQLI® (eculizumab-aagh) as a biosimilar to Soliris1 (eculizumab). EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
The FDA’s approval of EPYSQLI is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between EPYSQLI and Soliris in terms of safety, purity and potency: The randomized Phase I, double-blind, three-arm, parallel group, single-dose study in healthy volunteers (NCT03722329) demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, tolerability, and immunogenicity profiles between EPYSQLI and Soliris. The randomized Phase 3, double-blind, multicenter, cross-over study in PNH patients (NCT04058158) demonstrated clinical equivalence in efficacy, safety, PK, and immunogenicity between EPYSQLI and Soliris.
“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 healthcare systems by reducing healthcare costs and improving access to treatments,” said Christopher Hansung Ko, President and Chief Executive Officer at Samsung Bioepis. “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,” he added.
The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard treatment for PNH and aHUS, rare diseases with an estimated US prevalence of approximately 50,000 and 5,000 respectively.2,3 Approximately 70% of eculizumab-treated PNH patients are not dosed according to the label, and two-thirds of patients discontinue eculizumab within an average of 1.5 years, which may be attributed to several factors including the high treatment cost.4 Biosimilars, biologic medicines that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biologic, have the potential to relieve the financial burden of the healthcare system and improve access to biologic therapies.5 Biosimilar drugs must meet the same standards for pharmaceutical quality, safety and efficacy as reference products.
Outside of the US, EPYSQLI has also been approved by the European Commission (EC) and Korea’s Ministry of Food and Drug Safety (MFDS) as a biosimilar to Soliris for the treatment of patients with PNH and aHUS. In countries where EPYSQLI is approved and available, EPYSQLI may not be prescribed and/or dispensed for other indications for which Soliris is approved.
About EPYSQLI® (eculizumab-aagh) injection, for intravenous use
EPYSQLI is a complement inhibitor indicated for the treatment of patients with:
• paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
• atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
Limitation of Use: EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Please see the accompanying full Prescribing Information and Medication Guide for EPYSQLI, including BOXED WARNING regarding serious and life-threatening meningococcal infections.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.
1 Soliris is a trademark of Alexion Pharmaceuticals, Inc.
2 National Center for Advancing Translational Sciences. Paroxysmal nocturnal hemoglobinuria. https://rarediseases.info.nih.gov/diseases/7337/index
3 National Center for Advancing Translational Sciences. Atypical hemolytic uremic syndrome. https://rarediseases.info.nih.gov/diseases/8702/atypical-hemolytic-uremic-syndrome
4 Jun Ho Jang, Roberta Demichelis Gomez, Horia Bumbea, Larysa Nogaieva, Lily Lee Lee Wong, Soo Min Lim, Younsoo Kim, Jihye Park. A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria. https://doi.org/10.1002/jha2.632 Volume 4, 2022.
5 U.S. Food and Drug Administration. Biosimilars. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
SOURCE: Samsung Bioepis
Post Views: 4,067
