Teva and Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available in the United States
Teva Pharmaceuticals and Samsung Bioepis have announced the U.S. availability of EPYSQLI® (eculizumab-aagh), a biosimilar to Soliris®. The treatment is now accessible for patients with rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in AchR antibody positive adults.
EPYSQLI will be offered at a 30% discount compared to Soliris's Wholesale Acquisition Cost, making it one of the most cost-effective biosimilars in the U.S. The FDA approved EPYSQLI in July 2024 for PNH and aHUS treatments, with gMG indication added in November 2024.
Under their January 2025 partnership, Samsung Bioepis manages development, manufacturing, and supply, while Teva handles U.S. commercialization. The FDA has provisionally determined EPYSQLI to be interchangeable with Soliris® after exclusivity expiration for the first interchangeable biosimilar.
Teva Pharmaceuticals e Samsung Bioepis hanno annunciato la disponibilità negli Stati Uniti di EPYSQLI® (eculizumab-aagh), un biosimilare di Soliris®. Il trattamento è ora accessibile per i pazienti con malattie rare, tra cui emoglobinuria notturna parossistica (PNH), sindrome emolitica uremica atipica (aHUS) e miastenia grave generalizzata (gMG) negli adulti positivi agli anticorpi AchR.
EPYSQLI sarà offerto con un sconto del 30% rispetto al costo di acquisizione all'ingrosso di Soliris, rendendolo uno dei biosimilari più convenienti negli Stati Uniti. La FDA ha approvato EPYSQLI a luglio 2024 per i trattamenti di PNH e aHUS, con l'indicazione gMG aggiunta a novembre 2024.
Nel loro accordo di gennaio 2025, Samsung Bioepis gestisce lo sviluppo, la produzione e la fornitura, mentre Teva si occupa della commercializzazione negli Stati Uniti. La FDA ha determinato provvisoriamente che EPYSQLI è intercambiabile con Soliris® dopo la scadenza dell'esclusività per il primo biosimilare intercambiabile.
Teva Pharmaceuticals y Samsung Bioepis han anunciado la disponibilidad en EE. UU. de EPYSQLI® (eculizumab-aagh), un biosimilar de Soliris®. El tratamiento ya está accesible para pacientes con enfermedades raras, incluyendo hemoglobinuria nocturna paroxística (PNH), síndrome hemolítico urémico atípico (aHUS) y miastenia grave generalizada (gMG) en adultos positivos para anticuerpos AchR.
EPYSQLI se ofrecerá con un descuento del 30% en comparación con el costo de adquisición al por mayor de Soliris, convirtiéndolo en uno de los biosimilares más rentables en EE. UU. La FDA aprobó EPYSQLI en julio de 2024 para tratamientos de PNH y aHUS, con la indicación de gMG añadida en noviembre de 2024.
En su asociación de enero de 2025, Samsung Bioepis gestiona el desarrollo, la fabricación y el suministro, mientras que Teva se encarga de la comercialización en EE. UU. La FDA ha determinado provisionalmente que EPYSQLI es intercambiable con Soliris® después de la expiración de la exclusividad para el primer biosimilar intercambiable.
테바 제약과 삼성바이오에피스는 EPYSQLI® (에쿨리주맙-aagh)의 미국 내 출시를 발표했습니다. 이는 솔리리스®의 바이오시밀러입니다. 이 치료법은 파록시즘 야간 헤모글로빈뇨증 (PNH), 비전형 용혈성 요독 증후군 (aHUS), 그리고 AchR 항체 양성 성인에서의 일반화된 중증 근무력증 (gMG)과 같은 희귀 질환을 가진 환자들에게 접근 가능해졌습니다.
EPYSQLI는 솔리리스의 도매 인수 비용에 비해 30% 할인된 가격으로 제공될 예정이며, 이는 미국에서 가장 비용 효율적인 바이오시밀러 중 하나가 될 것입니다. FDA는 2024년 7월 PNH 및 aHUS 치료를 위해 EPYSQLI를 승인했으며, gMG 적응증은 2024년 11월에 추가되었습니다.
2025년 1월의 파트너십에 따라 삼성바이오에피스는 개발, 제조 및 공급을 관리하고, 테바는 미국 내 상업화를 담당합니다. FDA는 EPYSQLI가 첫 번째 바이오시밀러의 독점 기간 만료 후 솔리리스®와 교환 가능하다고 잠정적으로 결정했습니다.
Teva Pharmaceuticals et Samsung Bioepis ont annoncé la disponibilité aux États-Unis de EPYSQLI® (éculizumab-aagh), un biosimilaire de Soliris®. Ce traitement est désormais accessible aux patients atteints de maladies rares, notamment l'hémoglobinurie nocturne paroxystique (PNH), le syndrome hémolytique et urémique atypique (aHUS) et la myasthénie grave généralisée (gMG) chez les adultes positifs aux anticorps AchR.
EPYSQLI sera proposé avec un rabais de 30% par rapport au coût d'acquisition en gros de Soliris, ce qui en fait l'un des biosimilaires les plus rentables aux États-Unis. La FDA a approuvé EPYSQLI en juillet 2024 pour les traitements de PNH et aHUS, avec l'indication gMG ajoutée en novembre 2024.
Dans le cadre de leur partenariat de janvier 2025, Samsung Bioepis gère le développement, la fabrication et l'approvisionnement, tandis que Teva s'occupe de la commercialisation aux États-Unis. La FDA a provisoirement déterminé qu'EPYSQLI est interchangeable avec Soliris® après l'expiration de l'exclusivité pour le premier biosimilaire interchangeable.
Teva Pharmaceuticals und Samsung Bioepis haben die Verfügbarkeit von EPYSQLI® (eculizumab-aagh) in den USA angekündigt, einem Biosimilar zu Soliris®. Die Behandlung ist nun für Patienten mit seltenen Krankheiten zugänglich, darunter paroxysmale nächtliche Hämoglobinurie (PNH), atypisches hämolytisch-urämisches Syndrom (aHUS) und generalisierte Myasthenia gravis (gMG) bei AchR-Antikörper-positiven Erwachsenen.
EPYSQLI wird mit einem 30% Rabatt im Vergleich zu den Großhandelskosten von Soliris angeboten, was es zu einem der kosteneffektivsten Biosimilars in den USA macht. Die FDA hat EPYSQLI im Juli 2024 für die Behandlung von PNH und aHUS genehmigt, wobei die gMG-Indikation im November 2024 hinzugefügt wurde.
Im Rahmen ihrer Partnerschaft im Januar 2025 verwaltet Samsung Bioepis die Entwicklung, Herstellung und Lieferung, während Teva die Vermarktung in den USA übernimmt. Die FDA hat vorläufig festgestellt, dass EPYSQLI nach Ablauf der Exklusivität für das erste austauschbare Biosimilar mit Soliris® austauschbar ist.
- 30% cost reduction compared to reference drug Soliris
- FDA provisional determination of interchangeability with Soliris
- Addresses significant market with 55,000 potential patients in the US
- Strategic partnership leveraging both companies' strengths
- 70% of PNH patients don't follow proper dosing schedule
- Two-thirds of patients discontinue treatment within 1.5 years due to high costs
Insights
Teva's launch of EPYSQLI marks a strategic entry into the high-value rare disease market with a biosimilar offered at a 30% discount to Soliris's wholesale acquisition cost. This presents a meaningful competitive advantage in diseases where treatment costs have been prohibitive.
The targeted conditions—PNH, aHUS, and gMG—represent small but lucrative patient populations, with approximately 50,000 PNH and 5,000 aHUS patients in the US. Current market dynamics reveal significant opportunities: 70% of PNH patients receive non-label-compliant dosing and two-thirds discontinue therapy within 1.5 years, partly due to cost constraints.
The partnership structure optimizes capital efficiency, with Teva leveraging its established commercial infrastructure while Samsung Bioepis handles development and manufacturing. This arrangement allows Teva to enter a specialized therapeutic area without substantial upfront investment in manufacturing capabilities.
The pending interchangeability designation represents a future catalyst that could accelerate market penetration once exclusivity expires. In rare disease markets where annual treatment costs frequently exceed
The EPYSQLI launch represents a significant advancement in rare disease treatment accessibility. The
Three critical market access factors stand out: First, the high discontinuation rate (two-thirds within 1.5 years) among current Soliris patients signals substantial opportunity for a more affordable alternative to improve persistence. Second, the provisional interchangeability designation will eventually remove key prescribing barriers, though the timeline remains dependent on exclusivity expiration for the first interchangeable biosimilar.
Third, the partnership leverages Teva's established payer relationships and rare disease market experience while utilizing Samsung Bioepis's manufacturing expertise. This combination addresses both supply reliability concerns and formulary access requirements critical for specialty products.
For payers managing high-cost specialty categories, EPYSQLI offers immediate savings opportunities while potentially expanding the treatable population for these severe conditions. The biosimilar could ultimately normalize treatment patterns closer to label recommendations by removing cost barriers that currently drive suboptimal dosing in
- 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, N.J. and INCHEON, Korea, April 07, 2025 (GLOBE NEWSWIRE) -- 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
“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
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.
Use of Trademarks
Soliris® is a registered trademark of Alexion Pharmaceuticals, Inc.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
- Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of EPYSQLI, unless the risks of delaying therapy with EPYSQLI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor.
- Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called EPYSQLI REMS.
CONTRAINDICATIONS
EPYSQLI is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.
WARNINGS AND PRECAUTIONS
Serious Meningococcal Infections
Eculizumab products, complement inhibitors, increase a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EPYSQLI treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection.
Complete or update meningococcal vaccination (for serogroups A, C, W, Y, and B) at least 2 weeks prior to administration of the first dose of EPYSQLI, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations, considering the duration of therapy with EPYSQLI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EPYSQLI therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including eculizumab products. The benefits and risks of treatment with EPYSQLI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.
Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.
Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Meningococcal infection may become rapidly life- threatening or fatal if not recognized and treated early. Consider interruption of EPYSQLI in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated.
EPYSQLI REMS
EPYSQLI is available only through a restricted program under a REMS called EPYSQLI REMS, because of the risk of serious meningococcal infections.
Notable requirements of the EPYSQLI REMS include the following:
- Prescribers must enroll in the REMS.
- Prescribers must counsel patients about the risk of serious meningococcal infection.
- Prescribers must provide the patients with the REMS educational materials.
- Prescribers must assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of EPYSQLI.
- Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently and the patient is not up to date with meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of EPYSQLI.
- Healthcare settings and pharmacies that dispense EPYSQLI must be certified in the REMS and must verify prescribers are certified.
- Patients must receive counseling from the prescriber about the need to receive meningococcal vaccines per ACIP recommendations, the need to take antibiotics as directed by the prescriber, and the signs and symptoms of meningococcal infection.
- Patients must be instructed to carry the Patient Safety Card with them at all times during and for 3 months following treatment with EPYSQLI.
Further information is available at www.EPYSQLIREMS.com or 1-866-318-0342.
Other Infections
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
Eculizumab products block terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.
Monitoring Disease Manifestations after EPYSQLI Discontinuation
Treatment Discontinuation for PNH
Monitor patients after discontinuing EPYSQLI for at least 8 weeks to detect hemolysis.
Treatment Discontinuation for aHUS
After discontinuing EPYSQLI, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued eculizumab treatment. TMA complications occurred following a missed dose in 5 patients, and eculizumab was reinitiated in 4 of these 5 patients.
Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by
If TMA complications occur after EPYSQLI discontinuation, consider reinstitution of EPYSQLI treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.
Thrombosis Prevention and Management
The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.
Infusion-Related Reactions
Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt EPYSQLI infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.
ADVERSE REACTIONS
The most frequently reported adverse reactions in the PNH randomized trial (≥
The most frequently reported adverse reactions in aHUS single arm prospective trials (≥
The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥
DRUG INTERACTIONS
Plasmapheresis, Plasma Exchange, or Fresh Frozen Plasma Infusion
Concomitant use of eculizumab products with plasma exchange (PE), plasmapheresis (PP) or fresh frozen plasma infusion (PE/PI) treatment can reduce serum eculizumab product concentrations and requires a supplemental dose of EPYSQLI.
Neonatal Fc Receptor Blockers
Concomitant use of eculizumab products with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of eculizumab products. Closely monitor for reduced effectiveness of EPYSQLI.
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully commercialize EPYSQLI (eculizumab-aagh) in the U.S. for the treatment of the rare diseases: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG); our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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.
| Teva Media Inquiries | TevaCommunicationsNorthAmerica@tevapharm.com |
| Teva Investor Relations Inquiries | TevaIR@Tevapharm.com |
| Samsung Bioepis Media Inquiries | Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com |
FAQ
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