01 Table 1: Monoclonal Antibodies Pipeline of U.S.-Based Companies Company Name Product Name Development Phase Indication AbbVie Inc. Elezanumab (ABT-555) Phase-III Spinal Cord Injury AbbVie Inc. OpSCF Phase-III Atopic Dermatitis AbbVie Inc. ABBV-181 (budigalimab) Phase-III Solid Tumors AbbVie Inc. Livmoniplimab (ABBV-151) + Budigalimab (ABBV-181) Phase-III Liver, Solid Tumors, Non-Small Cell Lung Cancer AbbVie Inc. TTX-030 Phase-III Advanced Pancreatic Cancer AbbVie Inc. ABBV-141 Phase-II Idiopathic Pulmonary Fibrosis AbbVie Inc. ABBV-142 Phase-II Idiopathic Pulmonary Fibrosis Otsuka America Pharmaceutical, Inc Sibeprenlimab Investigational New Drug Application Submitted IgA Nephropathy Merck & Co., Inc. Clesrovimab (MK-1654) Under Review Respiratory Syncytial Virus Merck & Co., Inc. KEYTRUDA (MK-3475) Under Review 1L Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma Under Review Hepatocellular carcinoma (EU) Under Review Ovarian Cancer Under Review Small Cell Lung Cancer Phase- III Advanced Solid Tumors Phase- III Prostate Cancer Merck & Co., Inc. Tulisokibart (MK-7240) Under Review Crohn’s Disease Under Review Ulcerative Colitis Phase- III Systemic Sclerosis Merck & Co., Inc. Boserolimab (MK-5890) Phase-III Neoplasm Malignant Merck & Co., Inc. Quavonlimab (MK-1308) Phase-III Non-small Cell Lung Cancer Amgen Inc. Aimovig (erenumab-aooe) Phase-III Pediatric Migraine Amgen Inc. AMJEVITA (adalimumab-atto) Phase-III Interchangeability Amgen Inc. BEMARITUZUMAB Phase- III Gastric and Gastroesophageal Junction (GEJ) Cancers Phase- II Advanced Solid Tumors Amgen Inc. EVENITY (romosozumab-aqqg) Phase- III Male Osteoporosis Phase- III Pediatric Osteogenesis Imperfecta Amgen Inc. PROLIA (denosumab) Phase- III Pediatric Glucocorticoid-Induced Osteoporosis Amgen Inc. Repatha (evolocumab) Phase- III Hypercholesterolemia Amgen Inc. Rocatinlimab (formerly AMG 451 / KHK4083) Phase- III Atopic Dermatitis Phase- III Prurigo Nodularis Phase- II Asthma Amgen Inc. TEPEZZA (teprotumumab-trbw) Phase- III Thyroid Eye Disease Amgen Inc. TEZSPIRE (tezepelumab-ekko) Phase- III Severe Asthma Phase- III Chronic Rhinosinusitis with Nasal Polyps Phase- III Eosinophilic Esophagitis Phase- II Chronic Obstructive Pulmonary Disease Amgen Inc. UPLIZNA (inebilizumab-cdon) Phase- III IgG4-Related Disease Phase- III Myasthenia Gravis Phase- II Systemic Lupus Erythematosus with Nephritis Amgen Inc. DAXDILIMAB Phase- II Dermatomyositis and Anti-synthetase Inflammatory Myositis Phase- II Discoid Lupus Erythematosus Amgen Inc. ORDESEKIMAB (formerly AMG 714 / PRV-015) Phase- II Celiac Disease Amgen Inc. AMG 104 Phase-II Asthma Amgen Inc. AMG 329 (formerly HZN-1116) Phase-II Sjögren’s Disease Amgen Inc. AMG 355 Phase- I Solid Tumors Amgen Inc. AMG 691 Phase- I Asthma Amgen Inc. AMG 732 (formerly HZN-280) Phase- I Thyroid 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.