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Sandoz Group AG

Sandoz Group AG logo
🇨🇭Switzerland
Ownership
Public
Established
1986-01-01
Employees
20K
Market Cap
$19B
Website
http://www.sandoz.com

Clinical Trials

140

Active:1
Completed:123

Trial Phases

5 Phases

Phase 1:85
Phase 2:1
Phase 3:36
+2 more phases

Drug Approvals

52

SFDA:51
FDA:1

Drug Approvals

Proventil HFA

Approval Date
Jun 14, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (134 trials with phase data)• Click on a phase to view related trials

Phase 1
85 (63.4%)
Phase 3
36 (26.9%)
Not Applicable
7 (5.2%)
Phase 4
5 (3.7%)
Phase 2
1 (0.7%)

Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma

Not Applicable
Not yet recruiting
Conditions
Respiratory
First Posted Date
2025-10-31
Last Posted Date
2025-11-03
Lead Sponsor
Sandoz
Target Recruit Count
1430
Registration Number
NCT07223294
Locations
🇺🇸

Sandoz Investigational Site, Raleigh, North Carolina, United States

Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis

Phase 3
Recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Biological: CYB704
Biological: Ocrevus-EU
Biological: Ocrevus-US
First Posted Date
2025-02-26
Last Posted Date
2025-11-03
Lead Sponsor
Sandoz
Target Recruit Count
175
Registration Number
NCT06847724
Locations
🇷🇸

Sandoz Investigational Site, Niš, Serbia

Integrated PK/efficacy, safety, and immunogenicity study to demonstrate similarity of JPB898, a proposed biosimilar to nivolumab, to Opdivo® in combination with Yervoy®

Phase 3
Suspended
Conditions
Advanced (unresectable/metastatic) melanoma
Interventions
Drug: JPB898 (Induction and Maintenance)
Drug: Opdivo-EU (Induction)
Drug: Opdivo-US (Induction)
Drug: Yervoy-EU (Induction)
Drug: Opdivo-EU (Maintenance)
First Posted Date
2024-09-19
Last Posted Date
2025-08-07
Lead Sponsor
H e x a l AG
Target Recruit Count
302
Registration Number
2023-507865-24-00
Locations
🇨🇳

Sandoz Investigational Site, Taoyuan City, Taiwan

A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Phase 3
Suspended
Conditions
Metastatic NSCLC
Interventions
Drug: Keytruda-EU
First Posted Date
2023-12-07
Last Posted Date
2025-07-08
Lead Sponsor
Sandoz
Target Recruit Count
720
Registration Number
NCT06159790
Locations
🇻🇳

Sandoz Investigational Site, Hà Nội, Vietnam

A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

Phase 1
Recruiting
Conditions
Melanoma
Interventions
First Posted Date
2023-12-01
Last Posted Date
2025-07-09
Lead Sponsor
Sandoz
Target Recruit Count
318
Registration Number
NCT06153238
Locations
🇹🇷

Sandoz Investigational Site, Yüreğir, Turkey

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News

EirGenix Secures $152M Licensing Deal with Sandoz for HER2-Positive Breast Cancer Biosimilar

EirGenix signed a global exclusive licensing agreement with Sandoz for EG1206A, a pertuzumab biosimilar targeting HER2-positive breast cancer, worth up to $152 million in upfront and milestone payments.

FDA Proposes Streamlined Approval Pathway to Accelerate Biosimilar Drug Development

The U.S. FDA released draft guidance proposing to reduce human clinical study requirements for certain biosimilar drugs and treat them more like generic medications to accelerate market availability.

Alvotech Restructures Leadership Team with New Commercial Operations Appointments

Alvotech announced significant leadership changes with Chief Commercial Officer Anil Okay stepping down to become CEO of Adalvo, marking a strategic transition in the company's commercial operations.

Irish Court Invalidates Bayer's Rivaroxaban Dosing Patent in €3.5 Billion Xarelto Challenge

The High Court of Ireland ruled that Bayer's patent protecting once-daily dosing of rivaroxaban (Xarelto) was invalid for lack of inventive step, affecting a product worth €3.5 billion globally in 2024.

MacuMira Receives First Health Canada Approval for Non-Invasive Dry AMD Treatment Device

MacuMira Medical Devices has launched the first Health Canada-approved device to improve visual function in patients with dry age-related macular degeneration.

Australian Court Denies Preliminary Injunction Against Sandoz Aflibercept Biosimilar Launch

The Federal Court of Australia denied Regeneron and Bayer's preliminary injunction application against Sandoz's aflibercept biosimilars, allowing the launch of Afqlir and Enzeevu to proceed as planned.

Nevian Lifescience Launches First Locally Manufactured Novartis Medicine Following Bangladesh Acquisition

Nevian Lifescience PLC, formerly Novartis (Bangladesh) Limited, unveiled its first locally manufactured Novartis brand 'Galvus Met' following the acquisition by Radiant Pharmaceuticals Limited.

Sandoz Secures Patent Settlement with Regeneron, Clears Path for Aflibercept Biosimilar Launch by End of 2026

Sandoz reached a patent settlement agreement with Regeneron resolving all litigation related to its FDA-approved aflibercept biosimilar Enzeevu, clearing the path for US market entry by the fourth quarter of 2026.

High Court Strikes Out Sandoz's £3.9 Million Profit Claim Against Bayer in Rivaroxaban Patent Dispute

The High Court struck out Sandoz's claim for an account of profits against Bayer, reinforcing that cross-undertakings in patent litigation serve compensatory rather than restitutionary purposes.

Major Pharmaceutical Companies Face Surge in Generic Drug Patent Challenges in Early 2025

Major pharmaceutical companies including AstraZeneca, Novartis, and Astellas are defending patents for blockbuster drugs like Lynparza, Entresto, and Xtandi against generic manufacturers in early 2025.

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