- EPYSQLI® (eculizumab-aagh) is now available to patients living with difficult-to-treat rare diseases like paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive
- EPYSQLI will be available at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris® (eculizumab), making it one of the greatest cost-saving biosimilars to Soliris® in the U.S.
- Teva and Samsung Bioepis entered into a strategic partnership in January 2025 for the commercialization of EPYSQLI in the U.S., furthering both companies’ commitment to bring more accessible treatment options to rare disease patients
PARSIPPANY, NJ, USA and INCHEON, Korea I April 07, 2025 I Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Samsung Bioepis Co., Ltd. today announced the availability of EPYSQLI® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. EPYSQLI will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris®, offering one of the greatest cost-saving biosimilars to Soliris® in the U.S.
“Individuals living with rare diseases, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis, often have limited access to life-enhancing medicines,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “We are proud to launch EPYSQLI in the U.S. as a new, more affordable treatment option to help expand access to these underserved communities, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities.”
“Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and it is important for patients to have early access to treatment. The availability of EPYSQLI means that patients now have an additional treatment option available at a lower cost, with the proven quality, safety and efficacy comparable to the reference product. Based on our robust track record supplying biosimilars in the U.S., we are well-positioned to deliver this life-changing medicine to patients,” said Linda MacDonald, Executive Vice President and Head of Global Commercial Division of Samsung Bioepis. “Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines. We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.,” she added.
The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard of care to treat PNH and aHUS, rare diseases with an estimated U.S. prevalence of approximately 50,000 and 5,000 respectively.1,2 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 can be attributed to several factors including the high treatment cost.3 Biosimilars, like EPYSQLI, are highly similar to their reference product with no clinically meaningful differences in safety, purity, or potency, and can increase the affordability and accessibility associated with these therapies. Biosimilars are approved according to the same standards of pharmaceutical quality that apply to all biological medicines, with comparable safety and efficacy to the reference product expected.4 The introduction of biosimilars leads to higher utilization of the molecule as lower costs offer increased access to patients.5
In July 2024, EPYSQLI was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Soliris® for the treatment of patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of gMG in adult patients who are AchR antibody positive. The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris®, following the expiration of exclusivity for the first interchangeable biosimilar.
In January 2025, Teva and Samsung Bioepis entered into a strategic partnership for the commercialization of EPYSQLI in the U.S. market. Under the terms of the agreement, Samsung Bioepis handles development, manufacturing and supply, while Teva is responsible for the commercialization of the product in the U.S., leveraging its experience and extensive sales and marketing infrastructure.
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).
- EPYSQLI is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.
Please click here for full Prescribing Information for EPYSQLI, including BOXED WARNINGS.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
About Samsung Bioepis
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare 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.
References
- National Center for Advancing Translational Sciences. Paroxysmal nocturnal hemoglobinuria. https://rarediseases.info.nih.gov/diseases/7337/index.
- National Center for Advancing Translational Sciences. Atypical hemolytic uremic syndrome. https://rarediseases.info.nih.gov/diseases/8702/atypical-hemolytic-uremic-syndrome.
- Cheng WY, Sarda SP, Mody-Patel N, et al. Real-World Healthcare Resource Utilization (HRU) and Costs of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Receiving Eculizumab in a US Population. Adv Ther. 2021;38(8):4461-4479. doi:10.1007/s12325-021-01825-4.
- The U.S. Food and Drug Administration. Available at: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.
- The U.S. Food and Drug Administration. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.
SOURCE: Samsung Bioepis
Post Views: 1,183
- EPYSQLI® (eculizumab-aagh) is now available to patients living with difficult-to-treat rare diseases like paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive
- EPYSQLI will be available at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris® (eculizumab), making it one of the greatest cost-saving biosimilars to Soliris® in the U.S.
- Teva and Samsung Bioepis entered into a strategic partnership in January 2025 for the commercialization of EPYSQLI in the U.S., furthering both companies’ commitment to bring more accessible treatment options to rare disease patients
PARSIPPANY, NJ, USA and INCHEON, Korea I April 07, 2025 I Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Samsung Bioepis Co., Ltd. today announced the availability of EPYSQLI® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. EPYSQLI will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris®, offering one of the greatest cost-saving biosimilars to Soliris® in the U.S.
“Individuals living with rare diseases, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis, often have limited access to life-enhancing medicines,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “We are proud to launch EPYSQLI in the U.S. as a new, more affordable treatment option to help expand access to these underserved communities, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities.”
“Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and it is important for patients to have early access to treatment. The availability of EPYSQLI means that patients now have an additional treatment option available at a lower cost, with the proven quality, safety and efficacy comparable to the reference product. Based on our robust track record supplying biosimilars in the U.S., we are well-positioned to deliver this life-changing medicine to patients,” said Linda MacDonald, Executive Vice President and Head of Global Commercial Division of Samsung Bioepis. “Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines. We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.,” she added.
The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard of care to treat PNH and aHUS, rare diseases with an estimated U.S. prevalence of approximately 50,000 and 5,000 respectively.1,2 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 can be attributed to several factors including the high treatment cost.3 Biosimilars, like EPYSQLI, are highly similar to their reference product with no clinically meaningful differences in safety, purity, or potency, and can increase the affordability and accessibility associated with these therapies. Biosimilars are approved according to the same standards of pharmaceutical quality that apply to all biological medicines, with comparable safety and efficacy to the reference product expected.4 The introduction of biosimilars leads to higher utilization of the molecule as lower costs offer increased access to patients.5
In July 2024, EPYSQLI was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Soliris® for the treatment of patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of gMG in adult patients who are AchR antibody positive. The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris®, following the expiration of exclusivity for the first interchangeable biosimilar.
In January 2025, Teva and Samsung Bioepis entered into a strategic partnership for the commercialization of EPYSQLI in the U.S. market. Under the terms of the agreement, Samsung Bioepis handles development, manufacturing and supply, while Teva is responsible for the commercialization of the product in the U.S., leveraging its experience and extensive sales and marketing infrastructure.
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).
- EPYSQLI is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.
Please click here for full Prescribing Information for EPYSQLI, including BOXED WARNINGS.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
About Samsung Bioepis
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare 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.
References
- National Center for Advancing Translational Sciences. Paroxysmal nocturnal hemoglobinuria. https://rarediseases.info.nih.gov/diseases/7337/index.
- National Center for Advancing Translational Sciences. Atypical hemolytic uremic syndrome. https://rarediseases.info.nih.gov/diseases/8702/atypical-hemolytic-uremic-syndrome.
- Cheng WY, Sarda SP, Mody-Patel N, et al. Real-World Healthcare Resource Utilization (HRU) and Costs of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Receiving Eculizumab in a US Population. Adv Ther. 2021;38(8):4461-4479. doi:10.1007/s12325-021-01825-4.
- The U.S. Food and Drug Administration. Available at: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.
- The U.S. Food and Drug Administration. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.
SOURCE: Samsung Bioepis
Post Views: 1,183
