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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

139

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 (133 trials with phase data)• Click on a phase to view related trials

Phase 1
85 (63.9%)
Phase 3
36 (27.1%)
Not Applicable
6 (4.5%)
Phase 4
5 (3.8%)
Phase 2
1 (0.8%)

An Efficacy and Safety Study With Integrated Pharmacokinetics (PK) and Pharmacodynamic (PD) Assessment to Compare the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (RMS)

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
2025-09-05
Lead Sponsor
Sandoz
Target Recruit Count
518
Registration Number
NCT06847724
Locations
🇵🇱

Sandoz Investigational Site, Warsaw, Poland

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

Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis

Phase 1
Terminated
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2023-06-05
Last Posted Date
2023-09-28
Lead Sponsor
Sandoz
Target Recruit Count
38
Registration Number
NCT05887843
Locations
🇨🇦

Sandoz Investigational Site, Toronto, Ontario, Canada

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News

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.

Liquidia's YUTREPIA Achieves Rapid Market Uptake with 900+ Prescriptions in 11 Weeks Post-Approval

Liquidia Corporation's YUTREPIA (treprostinil) inhalation powder achieved over 900 unique patient prescriptions and 550 patient starts within 11 weeks of FDA approval for treating PAH and PH-ILD.

Lupin Partners with Sandoz to Commercialize Ranibizumab Biosimilar Across Multiple Global Markets

Lupin Limited has entered into a strategic partnership with Sandoz Group AG to commercialize its biosimilar ranibizumab across the European Union, Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia.

Contract Manufacturing Industry Report Reveals Impact of Global Conflicts and Inflation on Pharmaceutical Production

The 15th edition of the CMO industry analysis uses FDA NDA approvals as the primary performance indicator for contract manufacturing organizations.

Sandoz Plans Generic Semaglutide Launch in Canada with Up to 70% Price Reduction

Swiss generic manufacturer Sandoz plans to launch unbranded semaglutide weight-loss drugs in Canada at discounts of up to 70% compared to branded versions once patents expire next year.

German Federal Patent Court Revokes Key Xarelto Patent, Opening Door for Generic Competition

The German Federal Patent Court revoked Bayer's crucial Xarelto patent EP 1 845 961 due to lack of inventive step, contradicting its earlier 2024 opinion that assumed the patent's validity.

Canadian Real-World Study Shows Comparable Remission Rates Between Etanercept Biosimilars and Originator in Rheumatoid Arthritis

A Canadian real-world evidence study of 150 rheumatoid arthritis patients found no significant differences in remission outcomes between etanercept biosimilars (Brenzys and Erelzi) and the originator drug Enbrel.

Stelara Biosimilars Capture Market Share as J&J's Blockbuster Drug Faces 33.7% Sales Decline

Johnson & Johnson's Stelara experienced a dramatic 33.7% year-over-year sales decline to $1.08 billion in Q1 2025, driven by aggressive biosimilar competition following patent expiration in September 2023.

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