01 Table 1: Monoclonal Antibodies Pipeline of U.S.-Based CompaniesCompany NameProduct NameDevelopment PhaseIndicationAbbVie Inc.Elezanumab (ABT-555)Phase-IIISpinal Cord InjuryAbbVie Inc.OpSCFPhase-IIIAtopic DermatitisAbbVie Inc.ABBV-181 (budigalimab)Phase-IIISolid TumorsAbbVie Inc.Livmoniplimab (ABBV-151) + Budigalimab (ABBV-181)Phase-IIILiver, Solid Tumors, Non-Small Cell Lung CancerAbbVie Inc.TTX-030Phase-IIIAdvanced Pancreatic CancerAbbVie Inc.ABBV-141Phase-IIIdiopathic Pulmonary FibrosisAbbVie Inc.ABBV-142Phase-IIIdiopathic Pulmonary FibrosisOtsuka America Pharmaceutical, IncSibeprenlimabInvestigational New Drug Application SubmittedIgA NephropathyMerck & Co., Inc.Clesrovimab(MK-1654)Under ReviewRespiratory Syncytial VirusMerck & Co., Inc.KEYTRUDA(MK-3475)Under Review1L Unresectable Advanced or Metastatic Malignant Pleural MesotheliomaUnder ReviewHepatocellular carcinoma (EU)Under ReviewOvarian CancerUnder ReviewSmall Cell Lung CancerPhase- IIIAdvanced Solid TumorsPhase- IIIProstate CancerMerck & Co., Inc.Tulisokibart(MK-7240)Under ReviewCrohn’s DiseaseUnder ReviewUlcerative ColitisPhase- IIISystemic SclerosisMerck & Co., Inc.Boserolimab(MK-5890)Phase-IIINeoplasm MalignantMerck & Co., Inc.Quavonlimab(MK-1308)Phase-IIINon-small Cell Lung CancerAmgen Inc.Aimovig(erenumab-aooe)Phase-IIIPediatric MigraineAmgen Inc.AMJEVITA(adalimumab-atto)Phase-IIIInterchangeabilityAmgen Inc.BEMARITUZUMABPhase- IIIGastric and Gastroesophageal Junction (GEJ) CancersPhase- IIAdvanced Solid TumorsAmgen Inc.EVENITY(romosozumab-aqqg)Phase- IIIMale OsteoporosisPhase- IIIPediatric Osteogenesis ImperfectaAmgen Inc.PROLIA(denosumab)Phase- IIIPediatric Glucocorticoid-Induced OsteoporosisAmgen Inc.Repatha(evolocumab)Phase- IIIHypercholesterolemiaAmgen Inc.Rocatinlimab(formerly AMG 451 / KHK4083)Phase- IIIAtopic DermatitisPhase- IIIPrurigo NodularisPhase- IIAsthmaAmgen Inc.TEPEZZA(teprotumumab-trbw)Phase- IIIThyroid Eye DiseaseAmgen Inc.TEZSPIRE(tezepelumab-ekko)Phase- IIISevere AsthmaPhase- IIIChronic Rhinosinusitis with Nasal PolypsPhase- IIIEosinophilic EsophagitisPhase- IIChronic Obstructive Pulmonary DiseaseAmgen Inc.UPLIZNA(inebilizumab-cdon)Phase- IIIIgG4-Related DiseasePhase- IIIMyasthenia GravisPhase- IISystemic Lupus Erythematosus with NephritisAmgen Inc.DAXDILIMABPhase- IIDermatomyositis and Anti-synthetase Inflammatory MyositisPhase- IIDiscoid Lupus ErythematosusAmgen Inc.ORDESEKIMAB(formerly AMG 714 / PRV-015)Phase- IICeliac DiseaseAmgen Inc.AMG 104Phase-IIAsthmaAmgen Inc.AMG 329(formerly HZN-1116)Phase-IISjögren’s DiseaseAmgen Inc.AMG 355Phase- ISolid TumorsAmgen Inc.AMG 691Phase- IAsthmaAmgen Inc.AMG 732(formerly HZN-280)Phase- IThyroid Eye Disease
September 2025 Regeneron Pharmaceuticals expanded its monoclonal antibody capabilities through continued development of antibody platforms and manufacturing technologies to support next-generation biologic therapies.
July 2025 AstraZeneca expanded its biologics portfolio by advancing monoclonal antibody programs across oncology, respiratory, and immune-mediated disease areas, strengthening its position in antibody-based therapeutics.
June 2025 Johnson & Johnson expanded its monoclonal antibody pipeline through advancements in immunology and oncology biologics, focusing on development of targeted therapies for complex diseases.
May 2025 Roche expanded its monoclonal antibody portfolio by advancing antibody-based therapies and strengthening development programs in oncology and immunology, supporting continued innovation in targeted biologic treatments.