edgepedia

Biologics, monoclonal antibodies, and biosimilars

743 articles

Brazikumab

Brazikumab, known by the development codes AMG 139 and MEDI2070, is a monoclonal antibody against interleukin-23 that was investigated for Crohn's disease and ulcerative colitis.

Brenetafusp

Brenetafusp (IMC-F106C) is Immunocore's PRAME x CD3 ImmTAC bispecific TCR fusion protein for HLA-A*02:01-positive PRAME-expressing cancers, in Phase 3 (PRISM-MEL-301) for first-line advanced cutaneous melanoma with nivolumab and Phase 1/2 testing in ovarian and lung cancers.

Brexucabtagene autoleucel

Brexucabtagene autoleucel (Tecartus, KTE-X19) is Kite Pharma's autologous anti-CD19 CAR T-cell therapy for adult relapsed/refractory mantle cell lymphoma (FDA 2020) and B-cell precursor ALL (2021), dosed 1-2 × 10^6 CAR+ T cells/kg.

Briakinumab

Briakinumab (ABT-874, J695) is a fully human anti-IL-12/23p40 monoclonal antibody developed by Abbott for psoriasis and Crohn's disease; efficacious in psoriasis but withdrawn in 2011 and never marketed.

Brodalumab

Brodalumab (Siliq, Kyntheum, KHK4827) is a fully human anti-IL-17 receptor A monoclonal antibody for moderate-to-severe plaque psoriasis, approved in Japan (2016), the US (2017), and EU (2017), with a US boxed warning for suicidality and REMS distribution.

Brolucizumab

Brolucizumab (Beovu, codes ESBA1008/RTH258) is a single-chain antibody fragment anti-VEGF-A drug given by intravitreal injection for wet AMD (FDA-approved 2019) and diabetic macular edema (2022), with a distinct risk of intraocular inflammation and occlusive retinal vasculitis.

BSI-060T (PYX-106, anti-Siglec-15)

BSI-060T (PYX-106, aldastotug) is a fully human IgG1 anti-Siglec-15 antibody licensed by Pyxis Oncology from Biosion in 2022; its Phase 1 solid tumor trial was paused in December 2024 and the license terminated effective August 2026.

BSI-502

BSI-502 (ATI-052) is a humanized bispecific antibody targeting TSLP and IL-4Rα, discovered by Biosion and licensed to Aclaris Therapeutics in November 2024 for atopic dermatitis and asthma, now in Phase 1b trials.

Bulumtatug fuvedotin

Bulumtatug fuvedotin (BFv, 9MW2821), Mabwell's next-generation Nectin-4-targeting antibody-drug conjugate carrying MMAE via a homogeneous DAR 4 linker; phase I/II ORRs of 54.1% in urothelial and 50% in triple-negative breast cancer, with phase III trials ongoing.

Burosumab

Burosumab (Crysvita, KRN23) is a human IgG1 monoclonal antibody against FGF23, approved from 2018 for X-linked hypophosphatemia in children and adults and for tumor-induced osteomalacia, restoring renal phosphate reabsorption.

C-CAR039 (CD19/CD20 CAR-T)

C-CAR039 (prizloncabtagene autoleucel, Prizlon-cel, JNJ-90014496) is an autologous bispecific CD19/CD20 CAR-T therapy for relapsed/refractory B-cell lymphoma, developed by AbelZeta (formerly CBMG), licensed to Janssen for $245 million in 2023, with 91.5% ORR in Phase 1 and rights returned to AbelZeta in 2026.

C-CAR066 (CD20 CAR-T)

C-CAR066, an autologous fully human anti-CD20 CAR-T therapy from AbelZeta Pharma (formerly CBMG), licensed to Janssen in 2023 for $245M upfront; phase 1 in post-CD19 CAR-T relapsed/refractory LBCL showed 92.9% ORR, 57.1% CR, no ICANS.

Cadonilimab

Cadonilimab (AK104, 开坦尼), Akeso's tetravalent PD-1/CTLA-4 bispecific antibody with Fc-null design; first dual immune checkpoint bispecific approved (NMPA, June 2022) for cervical cancer, later gastric cancer.

Camrelizumab

Camrelizumab (AiRuiKa, SHR-1210), Jiangsu Hengrui's humanized anti-PD-1 monoclonal antibody; first approved in China 2019 for relapsed/refractory classical Hodgkin lymphoma, later nine NMPA indications; not FDA approved.

Cancer immunotherapy

Cancer immunotherapy: treatments that harness the immune system against tumors, chiefly checkpoint inhibitors (PD-1/PD-L1, CTLA-4), CAR-T cells, bispecifics, and vaccines; ~20-30% metastatic response rates, durable remissions, immune-related toxicities.

Caplacizumab

Caplacizumab (Cablivi, caplacizumab-yhdp) is an anti-von Willebrand factor nanobody approved in 2018-2019 for acquired thrombotic thrombocytopenic purpura, added to plasma exchange and immunosuppression; bleeding is its main risk.

CAR T-cell therapy

CAR T-cell therapy is an immunotherapy in which a patient's T cells are engineered with a chimeric antigen receptor to attack cancer cells, used mainly for blood cancers.

CAR-NK cell therapy

CAR-NK cell therapy is a cancer immunotherapy in which natural killer cells are engineered with chimeric antigen receptors to attack tumors, offering off-the-shelf donor-derived treatment.

Carotuximab

Carotuximab (TRC105, c-SN6j, DE-122) is an investigational chimeric IgG1 monoclonal antibody against endoglin (CD105) by TRACON Pharmaceuticals; phase II TRAXAR and phase III TAPPAS trials failed to show benefit, and it remains unapproved.

Catridecacog

Catridecacog (Tretten, NovoThirteen) is Novo Nordisk's recombinant coagulation factor XIII A-subunit made in yeast, given as 35 IU/kg monthly intravenously to prevent bleeding in congenital FXIII A-subunit deficiency.

Catumaxomab

Catumaxomab (Removab, Korjuny) is a bispecific trifunctional rat-mouse anti-EpCAM x anti-CD3 antibody for malignant ascites; EU-approved 2009, withdrawn 2017, reapproved 2025.

CBP-1018, bi-ligand drug conjugate

CBP-1018 (MVB-101), Coherent Biopharma's Bi-XDC bispecific peptide-drug conjugate targeting PSMA and FRalpha with an MMAE payload, in phase I/II trials for metastatic castration-resistant prostate cancer; licensed ex-Greater China to MultiValent Biotherapies for up to about USD 2 billion.

Cd24fc

CD24Fc (efprezimod alfa, MK-7110) is a CD24 extracellular domain fused to human IgG1 Fc, an innate immune checkpoint agonist developed by OncoImmune and Merck; its phase 3 COVID-19 trial was positive but development was discontinued in 2021.

Cell depletion therapy

Cell depletion therapy is a treatment that selectively eliminates defined cell populations, such as B cells, T cells, or cancer cells, using antibodies or engineered cells.

Cell- and Tissue-Based Therapy

Cell- and tissue-based therapy, or HCT/Ps, treats disease with living human cells or tissues, spanning stem cell transplants, CAR-T, and Tregzi (2026); FDA-approved products are few, while over 2,700 US clinics sell unproven versions.

Cemiplimab

Cemiplimab (Libtayo, cemiplimab-rwlc, REGN2810) is a fully human IgG4 PD-1 immune checkpoint inhibitor by Regeneron and Sanofi, FDA-approved since 2018 for advanced cutaneous squamous cell carcinoma, later adjuvant CSCC, basal cell carcinoma, and NSCLC.

Cendakimab

Cendakimab (RPC4046, CC-93538) is a humanized anti-IL-13 monoclonal antibody blocking IL-13Rα1/α2, in phase 3 development by Bristol Myers Squibb for eosinophilic esophagitis; not yet approved.

Cenegermin

Cenegermin (Oxervate, cenegermin-bkbj) is a recombinant human nerve growth factor eye drop, 20 µg/mL, six times daily for 8 weeks, approved by FDA (2018) and EMA (2017) for neurotrophic keratitis.

Cerliponase alfa

Cerliponase alfa (Brineura, rhTPP1) is BioMarin's intraventricular enzyme replacement therapy for CLN2 disease (Batten disease, TPP1 deficiency), FDA-approved 2017, slowing motor-language decline.

Certolizumab pegol

Certolizumab pegol (Cimzia), a PEGylated anti-TNFα Fab' fragment by UCB, treats rheumatoid arthritis, Crohn disease, axial spondyloarthritis, psoriatic arthritis, and psoriasis by subcutaneous injection.