RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Sequence Code 66437L

Source: *****

Sequence Code 66453H

Source: *****

Clinical Trials associated with Eculizumab

NCT05646563

/ Not yet recruitingPhase 2

A Phase II, Open-Label Study of NM8074 in Soliris®-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.

Start Date01 Jan 2027

Sponsor / Collaborator

NovelMed Therapeutics, Inc.

NCT07010302

/ Not yet recruitingPhase 4IIT

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.
In this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity.
Participants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant.
This research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.

Start Date01 May 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07410039

/ RecruitingPhase 4IIT

Eculizumab Add-On Therapy in the Acute Phase of Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Real-World Study

This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage. It comprehensively assesses the clinical outcomes of the patients and aims to compare the clinical efficacy and safety of icoxib as a combined add-on treatment versus simple hormone shock therapy during the acute phase of NMOSD.Using simple hormone shock therapy (IVMP) as the control group, the efficacy and safety of etanercept treatment in the acute attack phase of Chinese patients with AQP4-positive neuromyelitis optica spectrum disorder (NMOSD) were evaluated.

Start Date01 Feb 2026

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

100 Clinical Results associated with Eculizumab

100 Translational Medicine associated with Eculizumab

100 Patents (Medical) associated with Eculizumab

2,730

Literatures (Medical) associated with Eculizumab

31 Dec 2026·Hematology

Improvement in anemia and symptoms after switching from crovalimab to iptacopan in paroxysmal nocturnal hemoglobinuria

Article

Author: Onizuka, Makoto ; Ogawa, Yoshiaki ; Nasukawa, Miina ; Ogiya, Daisuke ; Koyama, Seina ; Machida, Shinichiro ; Kawada, Hiroshi ; Shiraiwa, Sawako ; Tomita, Shunsuke ; Endo, Motoki ; Toyosaki, Masako

OBJECTIVES:

Paroxysmal nocturnal hemoglobinuria (PNH) may develop breakthrough hemolysis (BTH) despite C5 inhibition. Although iptacopan, an oral factor B inhibitor, has demonstrated efficacy in phase 3 trials, switching from crovalimab has not been reported. We describe the first clinical case of this switch in a real-world clinical setting.

METHODS:

A 72-year-old man with long-standing PNH received eculizumab followed by crovalimab. Infectious enteritis triggered BTH and worsening anemia during crovalimab therapy. Because anemia persisted after recovery, iptacopan 200 mg twice daily was initiated three weeks after the final crovalimab administration. Clinical symptoms and laboratory parameters were followed for 12 months. This case report complied with the Declaration of Helsinki.

RESULTS:

Hemoglobin increased from 9.6 to 11.6 g/dL within two weeks and remained ≥12 g/dL thereafter. Dyspnea resolved within one week, vitality improved by two weeks, and no BTH or treatment-related adverse events occurred during follow-up.

DISCUSSION:

This case demonstrates the feasibility of switching from crovalimab to iptacopan despite the absence of an established method, and pharmacokinetic considerations guided the timing.

CONCLUSION:

Switching to iptacopan led to rapid and durable improvement in anemia and symptoms, supporting proximal complement inhibition as a valuable option for PNH patients inadequately controlled with C5 inhibitors.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost per responder analysis of iptacopan versus eculizumab and ravulizumab in treatment of paroxysmal nocturnal hemoglobinuria: implications for decision-making

Article

Author: Shafrin, Jason ; Muthukrishnan, Sanjana ; Kuypers, Nicholas ; Bilano, Ver ; Than, Kyi-Sin ; Paulose, Jincy

OBJECTIVE:

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and debilitating hematological disease with significant economic burden. Despite the availability of multiple therapies, there is a lack of consensus on optimal treatment strategies among physicians and payers in the United States. This study aimed to evaluate the economic value of iptacopan, a novel oral treatment option, compared to terminal complement inhibitors (specifically, complement component C5 inhibitor or C5i)-including eculizumab and ravulizumab-among patients with PNH who are either (i) C5i-experienced or (ii) complement-inhibitor-naïve.

METHODS:

A cost per responder analysis was conducted based on treatment efficacy from clinical trials comparing iptacopan with C5i treatments. Treatment response was defined as the proportion of patients achieving red blood cell transfusion independence. Treatment costs were estimated as pharmaceutical wholesale acquisition cost and treatment administration costs, accounting for discontinuation. Outcomes evaluated included the number needed to treat to achieve a response and the cost per responder over the treatment duration of 24 weeks.

RESULTS:

Over 24 weeks, the number needed to treat to achieve an additional response was lower for iptacopan than all C5i comparators (C5i-experienced: 1.05 with iptacopan vs. 3.86 with C5is; complement-inhibitor-naïve: 1.02 with iptacopan vs. 1.69 with C5is). Cost per responder was lower for iptacopan than C5i comparators for both C5i-experienced ($264,337 for iptacopan vs. $975,298 for ravulizumab, $1,060,511 for eculizumab, and $744,561-$955,194 for eculizumab biosimilar with 10%-30% discount from eculizumab cost) and complement-inhibitor-naïve patients ($256,754, vs. $428,139 for ravulizumab, $465,546 for eculizumab, and $326,849-$419,314 for eculizumab biosimilar).

CONCLUSION:

Among both C5i-experienced and complement-inhibitor-naïve patients, treatment with iptacopan resulted in higher response rates and lower cost per responder compared to C5is.

01 Jun 2026·IMMUNOLOGY LETTERS

Complement involvement in antiphospholipid syndrome

Review

Author: Darnige, Luc ; Dragon Durey, Marie-Agnès ; Hamidi, Houcine

Antiphospholipid syndrome (APS) is an acquired thrombophilia characterized by thrombotic and non-thrombotic (or non-criteria) manifestations, in the context of persistent presence of autoantibodies targeting phospholipids and associated proteins. The complement system, which shares common actors with coagulation cascade, is nowadays well established to be implicated in APS pathophysiology in different ways. Animal models using knock out strains or complement blocking therapies have helped to decipher the different complement components implicated in the processes of thrombosis and fetal morbidity. In APS patients, complement activation may be assessed through the detection of activation fragments (C4d, C3a, C5a, sC5b9) in plasma and on blood cells surface (C4d, C3d and C5b9) or on APS-affected tissues such as cardiac valves, vessels walls, kidneys and placentae. APS patients are currently treated to avoid thrombosis recurrence by long-term treatment by vitamin K antagonists but various complement targeting molecules are tested in trials or now available and may be of major interest to treat APS patients. Several cases report described the use of eculizumab, an anti-C5 monoclonal antibody, to treat severe forms of APS (recurrent thrombosis, Catastrophic APS) but these studies are not sufficient and need to be more standardized. C4d measurement may be useful to assess classical and lectin pathways activation, C5a may allow evaluating the C5a/C5aR axis activity whereas, associated with sC5b9, it may also assess the terminal pathway activation but also the therapeutic efficacy of complement blocking molecules. Thus, assessment of good complement biomarkers and their kinetics needs to be done to determine personalized therapeutic options.

288

News (Medical) associated with Eculizumab

10 Apr 2026

·www.astrazeneca.com

Alexion data at 2026 AAN Annual Meeting reflects industry-leading portfolio and commitment to enhancing care across rare diseases

Alexion, AstraZeneca Rare Disease, will deliver 20 presentations, including five oral presentations across generalised myasthenia gravis (gMG), neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN) and neuromyelitis optica spectrum disorder (NMOSD) at the American Academy of Neurology (AAN) Annual Meeting in Chicago, Illinois, 18 to 22 April 2026. Key presentations will include new results from the PREVAIL Phase III trial evaluating novel dual-binding nanobody gefurulimab in adults with anti-acetylcholine receptor (AChR) antibody-positive (Ab+) gMG as well as a new sub-study from the KOMET Phase III trial evaluating Koselugo (selumetinib) in adults with NF1 who have symptomatic, inoperable PN. An oral presentation will share new transcriptomics data from the CHAMPION-NMOSD Phase III trial, and additional presentations will highlight real-world evidence, including radiological outcomes, on the approved use of Ultomiris (ravulizumab) in NMOSD. Christophe Hotermans, Senior Vice President, Head of Global Medical Affairs, Alexion, said: “At AAN 2026, we will have our broadest set of neurology data to date, with presentations showcasing our rare disease portfolio and pipeline innovation across gMG, NMOSD and NF1-PN. New data from the PREVAIL Phase III trial will reinforce C5 inhibition in gMG, with investigational once-weekly self-administered gefurulimab showing rapid, sustained improvements through 26 weeks and new insights from the KOMET Phase III trial will highlight Koselugo’s impact in adults with NF1-PN. These findings reflect Alexion’s determination to advance innovations that make a meaningful impact for patients.” New data highlights gefurulimab potential as an effective, self-administered treatment option for gMG An oral presentation from the global PREVAIL Phase III trial will share new results evaluating gefurulimab as a self-administered, once-weekly subcutaneous treatment option for adults with gMG. New data will show statistically significant and clinically meaningful improvement in the secondary endpoint of change in Myasthenia Gravis Composite at Week 26 compared to placebo (treatment difference, -3.1 [0.69]; P<0.0001), expanding on data previously presented at the 2025 Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. Oral presentations spotlight meaningful symptom improvement with Koselugo, including reductions in pain in adult NF1-PN A qualitative sub-study conducted with participants from KOMET, the largest and only placebo-controlled global Phase III trial in adults with NF1-PN, will show that patients on Koselugo reported noticeable decreases in pain, tingling, PN size and improvement in sleep, fatigue and body movements that were sustained or further improved over the course of the trial. Finally, an oral presentation of retrospective US claims data over three years will demonstrate lasting reductions in prescription pain medication utilisation among adults with NF1-PN taking Koselugo. Alexion presentations during the 2026 AAN Annual Meeting Lead Author Abstract Title Presentation Details Lead Author gMG Lead Author Gwathmey, K. Abstract Title Efficacy and Safety of Subcutaneous Self-Administered Gefurulimab in Generalized Myasthenia Gravis: Primary Results From the Phase 3, Randomized, Double-Blind, Placebo-Controlled PREVAIL Study Presentation Details Oral Presentation 006 Abstract #1879 20 April 2026 02:00 PM CT Lead Author Juel, V. Abstract Title MG-ADL Subdomain Score Changes With Eculizumab or Ravulizumab: An Analysis of the Global MG SPOTLIGHT Registry (Encore) Presentation Details Poster Presentation Abstract #1774 20 April 2026 08:00 – 09:00 AM CT Lead Author Berling, E. Abstract Title Validation of ME&MGTM Digital Biomarkers in Monitoring Generalized Myasthenia Gravis Symptoms: The DOMYA Study* Presentation Details Poster Presentation Abstract #2859 21 April 2026 05:00 – 06:00 PM CT Lead Author Barnett-Tapia, C. Abstract Title ME&MGTM Digital Biomarkers Correlate with Equivalent MG-ADL and MG-QoL15r Sub-items Scores* Presentation Details Poster Presentation Abstract #2851 21 April 2026 05:00 – 06:00 PM CT Lead Author Yungher, B. Abstract Title The Phase 4 OCTAGON Study Investigating Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis (gMG) Treated With Ravulizumab: Trial in Progress Presentation Details Poster Presentation Abstract #2146 21 April 2026 05:00 – 06:00 PM CT Lead Author Nowak, R. Abstract Title Concomitant Immunosuppressive Therapy Use With Ravulizumab: Analysis of the Global MG SPOTLIGHT Registry (Encore) Presentation Details Poster Presentation Abstract #1761 21 April 2026 05:00 – 06:00 PM CT Lead Author Shugars, C. Abstract Title Patient Satisfaction With Ravulizumab Treatment for Generalized Myasthenia Gravis (gMG) in the United States (US) Presentation Details Poster Presentation Abstract #1868 22 April 2026 11:45 AM – 12:45 PM CT Lead Author Snook, R. Abstract Title Impact on Healthcare Resource Utilization in Early Initiators of Ravulizumab or Efgartigimod for Treatment of Generalized Myasthenia Gravis in the USA (Encore) Presentation Details Poster Presentation Abstract #1694 22 April 2026 11:45 AM – 12:45 PM CT Lead Author Mahler, J. Abstract Title Real-World Biologics in Generalized Myasthenia Gravis: Evidence for Reduced Hospitalization Rates (Encore) Presentation Details Poster Presentation Abstract #3312 22 April 2026 11:45 AM – 12:45 PM CT Lead Author NF1 Lead Author Lyons, G. Abstract Title Effect of Selumetinib Treatment on Long-Term Prescription Pain Medication Utilization in Adults: A Retrospective Study of a US Claims Database Presentation Details Oral Presentation 006 Abstract #4173 20 April 2026 02:00 PM CT Lead Author Swampillai, A. Abstract Title Adult Patients' Experiences with Selumetinib Treatment Versus Placebo for Neurofibromatosis Type 1-Plexiform Neurofibroma Associated Symptoms and Their Impacts: A Qualitative Sub-Study of a Phase 3, Placebo-Controlled Trial (KOMET) Presentation Details Oral Presentation 007 Abstract #3807 20 April 2026 02:12 PM CT Lead Author NMOSD Lead Author Pittock, S. Abstract Title Gene Expression Signatures Associated With Prior Rituximab Treatment in Patients With Anti-Aquaporin-4 Antibody-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD) in the CHAMPION-NMOSD Trial Presentation Details Oral Presentation 007 Abstract #2164 19 April 2026 02:12 PM CT Lead Author Sotirchos, E. Abstract Title Real-World Clinical Outcomes With Eculizumab and Ravulizumab in Anti-Aquaporin-4 Antibody-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Results From the Global NMO SPOTLIGHT Registry (Encore) Presentation Details Oral Presentation 009 Abstract #3238 19 April 2026 02:36 PM CT Lead Author Wruble, M. Abstract Title The Predictive Value of Billing Codes and Treatment Data to Identify Relapse Hospitalizations among Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) (Encore) Presentation Details Poster Presentation Abstract #4999 19 April 2026 08:00 – 09:00 AM CT Lead Author Sato, W. Abstract Title A real-world study of the effectiveness and safety of ravulizumab in AQP4-Ab+ NMOSD patients with suboptimal response to satralizumab in Japan - interim analysis (Encore) Presentation Details Poster Presentation Abstract #3426 19 April 2026 05:00 – 06:00 PM CT Lead Author Bernitsas, E. Abstract Title Financial and Mental Health Burden on Caregivers of Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) in the United States Presentation Details Poster Presentation Abstract #2135 19 April 2026 05:00 – 06:00 PM CT Lead Author Okuda, D. Abstract Title Clinical and Radiological Outcomes in People with Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Following Ravulizumab Treatment (AMAZE) Presentation Details Poster Presentation Abstract #4722 20 April 2026 08:00 – 09:00 AM CT Lead Author Conway, D. Abstract Title Latent Class Analysis (LCA) of Treatment Preferences Among Adults With Anti-Aquaporin-4 Antibody-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD) in the United States Presentation Details Poster Presentation Abstract #2092 20 April 2026 05:00 – 06:00 PM CT Lead Author Bhattacharyya, S. Abstract Title Quantifying the Lifetime Health and Societal Benefits From Earlier Diagnosis and Access to Approved Targeted Immunotherapies in Anti-Aquaporin-4 Antibody-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD) in the United States Presentation Details Poster Presentation Abstract #2080 21 April 2026 08:00 – 09:00 AM CT Lead Author Pittock, S. Abstract Title Long-term Efficacy and Safety of Ravulizumab in Anti-aquaporin-4 Antibody-positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Final Analysis of the Phase 3 CHAMPION-NMOSD Trial (Encore) Presentation Details Poster Presentation Abstract #1923 21 April 2026 08:00 – 09:00 AM CT *Ad Scientiam research study supported by Alexion Notes Alexion Alexion, AstraZeneca Rare Disease, is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. Corporate and financial

Phase 3Clinical Result

18 Mar 2026

·www.fiercepharma.com

Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's Entyvio

Sandoz has inked a deal with Korean biosimilars specialist Samsung Bioepis to commercialize up to five copycats, including a knockoff of Takeda's Entyvio. Sandoz has struck a deal with Samsung Bioepis to partner on up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio (vedolizumab), which is being developed by the South Korea-based biosimilars specialist. Switzerland-based Sandoz gains the right to commercialize the biosimilars around the world, with Samsung Bioepis retaining commercial rights in China, Hong Kong, Taiwan, Macau and its home country. Samsung Bioepis will continue to develop, manufacture and handle the regulatory submissions for the biosimilars. Financial terms of the partnership were not disclosed. The deal, which builds on the existing partnership of the companies, has the potential to expand Sandoz’s biosimilar portfolio to an “industry-leading” 32 assets, the company said in a release. The growing pipeline of products will allow Sandoz to capture a “significant share” of the $320 billion biosimilar loss-of-exclusivity market opportunity in the next decade, the company added.The companies initially got together in 2023, with Sandoz gaining commercial rights to Samsung’s Pyzchiva (ustekinumab), which is a knockoff of Johnson & Johnson’s Stelara. Sandoz launched it in Europe in July 2024 and in the U.S. in February 2025. Three months ago, the companies also paired up on Epysqli (eculizumab), which is Samsung’s biosimilar version of AstraZeneca’s Soliris.With the most recent agreement, analysts from Jefferies credited Sandoz’s “commercial infrastructure” as key to its ability to attract partners. They also noted that the Samsung Bioepis arrangement provides Sandoz with “improved long-term visibility on both R&D productivity and future launch cadence.” Samsung Bioepis plans to expand its biosimilar portfolio by 20 products by 2030, the company said two months ago at the J.P. Morgan Healthcare Conference. In addition to its Entyvio copycat, the company said it will develop biosimilar versions of Regeneron and Sanofi’s Dupixent, Johnson & Johnson’s Tremfya, Daiichi Sankyo and AZ’s Enhertu, Roche’s Ocrevus and Eli Lilly’s Taltz.As for Samsung and Sandoz’s plan to sell their Entyvio knockoff, Takeda has said its regulatory protection on the ulcerative colitis and Crohn’s disease treatment extends into May 2026. But some patents on the drug expire in 2032, according to the company's most recent annual report (PDF).“Any biosimilar that seeks to launch prior to 2032 would need to address potential infringement and/or the validity of all relevant patents and therefore the exact timing of biosimilar entry is uncertain,” the Japanese company explained in the report.For the last three quarters of 2025, Takeda reported Entyvio worldwide sales were up by 7% at 744.5 billion Japanese yen ($4.98 billion), with U.S. sales accounting for 494.8 billion Japanese yen ($3.03 billion).

License out/inDrug ApprovalBiosimilar

18 Mar 2026

·www.sandoz.com

Sandoz announces partnership agreement with Samsung Bioepis on up to five biosimilars, further expanding its leading pipeline to up to 32 assets

MEDIA RELEASE Agreement for up to five biosimilar assets, with potential for further collaboration; first asset to be vedolizumab biosimilar Collaboration builds on successful existing partnership; further strengthens Sandoz global position in biosimilars and could expand industry-leading pipeline to up to 32 assets Reinforces commitment to capture significant share of projected ~USD 320 billion biosimilar loss-of-exclusivity market opportunity over next decade1 Basel, March 18, 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced a major license, development and commercialization partnership agreement with Samsung Bioepis Co., Ltd., marking a significant step to broaden patient access to high-quality biosimilar medicines worldwide. The agreement paves the way for the two companies to partner on up to five biosimilar assets. The first asset will be a vedolizumab biosimilar, which is in early-stage development. The reference medicine, Entyvio®* (vedolizumab), is used to treat adult patients with Crohn’s disease, ulcerative colitis or pouchitis2,3. Under the terms of the agreement, Sandoz will have exclusive rights to commercialize globally, except in China, Hong Kong, Taiwan, Macau and Republic of Korea. Samsung Bioepis will be responsible for development, regulatory submissions in key markets and manufacturing. Both companies have agreed to keep the financial details of the agreement confidential. The partnership could expand the leading Sandoz pipeline to up to 32 assets and reinforces its commitment to capturing a significant share of the projected global biosimilar loss-of-exclusivity market opportunity, estimated at around USD 320 billion over the next decade1. Richard Saynor, Chief Executive Officer, Sandoz, said: ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalizing on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.” Today’s news builds on the successful global partnership between the two companies first established in September 2023 for Pyzchiva® (ustekinumab), which Sandoz launched in Europe in July 2024 and in the US in February 2025. The Pyzchiva collaboration is unaffected by the partnership announced today. In December 2025, the companies also signed an agreement for the commercialization of Epysqli™, a biosimilar to eculizumab (Soliris®**), for the Middle East and Africa region. Sandoz continues to develop its leading pipeline of biosimilar medicines, building on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries. *Entyvio® is a registered trademark of Takeda.**Soliris® is a registered trademark of Alexion. DISCLAIMER This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES 1 Covers US and EU markets (2026–2035). Originator sales and LoE based on internal analysis of data from multiple subscription databases. Biosimilar data accessed in September 2025.2 European Medicines Agency (EMA). Entyvio. Summary of Product Characteristics. Available at: Entyvio, INN-vedolizumab. [Last accessed March 2026]3 FDA. Entyvio. Prescribing Information. Available at: ENTYVIO. [Last accessed March 2026] ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alexis Kalomparis +41 79 279 0285 Craig Marks +44 78 1894 2383 Chris Lewis+49 174 244 9501 Tamara Hackl+41 79 790 5217 Gregor Rodehueser+49 170 574 3200 Silvia Siegfried+41 79 795 90 61

License out/in

100 Deals associated with Eculizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03940	Eculizumab	L04AA25	DB01257

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
AQP4-IgG positive Neuromyelitis optica spectrum disorder	Australia	Alexion Pharmaceuticals, Inc.	20 Mar 2009
Atypical Hemolytic Uremic Syndrome	European Union	Alexion Europe SAS	20 Jun 2007
Atypical Hemolytic Uremic Syndrome	Iceland	Alexion Europe SAS	20 Jun 2007
Atypical Hemolytic Uremic Syndrome	Liechtenstein	Alexion Europe SAS	20 Jun 2007
Atypical Hemolytic Uremic Syndrome	Norway	Alexion Europe SAS	20 Jun 2007
Myasthenia Gravis	European Union	Alexion Europe SAS	20 Jun 2007
Myasthenia Gravis	Iceland	Alexion Europe SAS	20 Jun 2007
Myasthenia Gravis	Liechtenstein	Alexion Europe SAS	20 Jun 2007
Myasthenia Gravis	Norway	Alexion Europe SAS	20 Jun 2007
Neuromyelitis Optica	European Union	Alexion Europe SAS	20 Jun 2007
Neuromyelitis Optica	Iceland	Alexion Europe SAS	20 Jun 2007
Neuromyelitis Optica	Liechtenstein	Alexion Europe SAS	20 Jun 2007
Neuromyelitis Optica	Norway	Alexion Europe SAS	20 Jun 2007
Hemoglobinuria, Paroxysmal	United States	Alexion Pharmaceuticals, Inc.	16 Mar 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Delayed Graft Function	Phase 3	United States	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Australia	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Brazil	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Canada	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Czechia	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	France	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Germany	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Italy	Alexion Pharmaceuticals, Inc.	21 Aug 2014
Delayed Graft Function	Phase 3	Spain	Alexion Pharmaceuticals, Inc.	21 Aug 2014
AQP4-IgG positive Optic Neuritis	Phase 3	United States	Alexion Pharmaceuticals, Inc.	11 Apr 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Atypical Hemolytic Uremic Syndrome \| Hemoglobinuria, Paroxysmal \| Pancytopenia ... View more	96	Eculizumab	ncuqgidgso(lplbcfelnq) = bprznunokp xjtjhaawic (nawxofwctr )	Positive	06 Dec 2025
				Eculizumab (immune competent cohort)	ljhyeaiuth(hwhpqivenc) = pvanykgzhx uncvcuogml (dfxxrawgfl )
ASH2025	Not Applicable	Thrombotic Microangiopathies	21	Eculizumab	tnxndngnpj(fhsampaqbd) = ngbeumtnjd fachsofvvg (erkgzwvbmu ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Hemoglobinuria, Paroxysmal \| Myeloproliferative Disorders	11	Eculizumab	skfrksmudc(kigoxvzkxb) = Sepsis as the cause of death in 3 cases bwhcqksnej (isdfdxphya )	Negative	06 Dec 2025
ASH2025	Not Applicable	Hemoglobinuria, Paroxysmal	31	Iptacopan	jminfzcsov(owrbepbatk) = iirgwtkhkh ujrxljwjad (ysitahnogo ) View more	Positive	06 Dec 2025
				Eculizumab	jminfzcsov(owrbepbatk) = wzlbxbhzzt ujrxljwjad (ysitahnogo ) View more
ASH2025	Not Applicable	Hemoglobinuria, Paroxysmal	87	eculizumab	owjauzaoui(zkbplkhqwt) = ntfxnfapkh dctiwgqymb (srttqhodna ) View more	Positive	06 Dec 2025
				ravulizumab	owjauzaoui(zkbplkhqwt) = vjwbrdntdf dctiwgqymb (srttqhodna ) View more
NCT05966467 (NMO SPOTLIGHT Registry, ECTRIMS2025 \| Company_Website) Manual	Not Applicable	AQP4-IgG positive Neuromyelitis optica spectrum disorder AQP4-IgG	56	ALXN-C5IT (eculizumab or ravulizumab)	aqxdmrxpou(xscpoxnhbc) = hclwjbnczb unpeddwmkd (fbrazwyvko, 0.00 - 0.05) View more	Positive	09 Sep 2025
				ALXN-C5IT (eculizumab or ravulizumab) (switched from rituximab)	aqxdmrxpou(xscpoxnhbc) = mazbjxpxqu unpeddwmkd (fbrazwyvko ) View more
PB2827 (EHA2025)	Not Applicable	Hemoglobinuria, Paroxysmal	52	Eculizumab	qfvaivlbut(cntbwfhras) = occurred in 30.8% nhgvrenvmh (unthrjbmji ) View more	-	14 May 2025
NCT05966467 (NMO SPOTLIGHT Registry, AAN2025)	Not Applicable	AQP4-IgG positive Neuromyelitis optica spectrum disorder	30	Eculizumab	hpvooobcyq(ozulzugahl) = aymrakkxjk rtrnivgmho (cgipjsqumh, 24.0 - 49.7)	Positive	07 Apr 2025
				Ravulizumab	hpvooobcyq(ozulzugahl) = dovsipktyy rtrnivgmho (cgipjsqumh, 0.7 - 1.3)
S34.006 (AAN2025)	Not Applicable	Myasthenia Gravis anti-acetylcholine receptor antibody-positive (AChR-Ab+)	254	Eculizumab	tzyhlfkqzz(vqttcsuuxx) = 40.5% experienced adverse drug reactions (ADRs) kfhhkogiin (ixkqtwrpxc ) View more	Positive	07 Apr 2025
ASH2024	Not Applicable	Atypical Hemolytic Uremic Syndrome	-	Eculizumab	aeitflxeuw(cosuoyzhaq) = depsuyvsvd awkljlxlmy (byjausgecm, 230.0 - 362.0) View more	-	08 Dec 2024
				Ravulizumab	ehfrfotgto(vgkhzgmdpf) = gycanpjsrb gahhmeisfp (omdjmftdfe, 11.5% - 36.4%)

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