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NIVOLUMAB biosimilars

Complete NIVOLUMAB (NIVOLUMAB) biosimilar landscape: 7 approved biosimilars, 0 filed, 8 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

7 approved 0 filed 8 Phase 3 All key patents expired

About NIVOLUMAB

NIVOLUMAB. Class: Programmed Death Receptor-1 Blocking Antibody [EPC]. First approved 2015-01-01.

Approved biosimilars (7)

BiosimilarSponsorPhaseFirst approvalCountry
Opdivo Bristol-Myers Squibb marketed 2014-01-01
Nivolumab and Relatlimab University of Wisconsin, Madison marketed
Nivolumab and Ipilimumab Pfizer Inc. marketed
Nivolumab in combination with Ipilimumab Bristol-Myers Squibb marketed
Nivolumab and/or Ipilimumab Pfizer Inc. marketed
Nivolumab plus Platinum Doublet Chemotherapy Galvanize Therapeutics, Inc. marketed
Nivolumab + Relatlimab H. Lee Moffitt Cancer Center and Research Institute marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (8)

BiosimilarSponsorPhaseFirst approvalCountry
Nivolumab & Ipilimumab The First Affiliated Hospital of Guangzhou Medical University phase 3
Nivolumab Injection UNICANCER phase 3
Nivolumab and Recombinant Human Hyaluronidase SWOG Cancer Research Network phase 3
nivolumab plus relatlimab Immatics US, Inc. phase 3
Nivolumab/rHuPH20 Bristol-Myers Squibb phase 3
Nivolumab or pembrolizumab Asan Medical Center phase 3
Nivolumab and rHuPH20 Bristol-Myers Squibb phase 3
Nivolumab-relatlimab FDC Bristol-Myers Squibb phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on NIVOLUMAB or any of its biosimilars:

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