edgepedia

Biologics, monoclonal antibodies, and biosimilars

743 articles

Luspatercept

Luspatercept (REBLOZYL, ACE-536) is an erythroid maturation agent, an activin receptor IIB-Fc fusion protein binding TGF-beta ligands, approved 2019 for anemia in beta thalassemia and myelodysplastic syndromes, dosed 1 mg/kg subcutaneously every 3 weeks.

Lutetium oxodotreotide

Lutathera (lutetium (177Lu) oxodotreotide, lutetium Lu 177 dotatate) is a radiolabeled somatostatin analog for SSTR-positive GEP-NETs; EU approval 2017, US 2018, dosed 7.4 GBq every 8 weeks for four cycles.

Lutikizumab

Lutikizumab (ABT-981), AbbVie's dual-variable domain antibody neutralizing IL-1α and IL-1β; failed osteoarthritis phase 2 trials but positive phase 2 hidradenitis suppurativa results, now in phase 3.

Lutropin alfa

Lutropin alfa (Luveris) is recombinant human luteinizing hormone made in CHO cells, approved in the EU in 2000 and by FDA in 2004 for follicular development with FSH in women with severe LH deficiency (LH < 1.2 IU/l).

LZM009 (anti-PD-1 antibody)

LZM009, also known as lipustobart (利普苏拜单抗), is a humanized anti-PD-1 monoclonal antibody developed by China's Livzon Mabpharm, trialed in thymic carcinoma and licensed to Bright Peak Therapeutics.

M-1095

M-1095 (sonelokimab, formerly ALX-0761) is a trivalent camelid nanobody inhibiting IL-17A and IL-17F with an albumin-binding domain, developed by MoonLake for psoriasis, psoriatic arthritis, and hidradenitis suppurativa.

mAbs

mAbs (Monoclonal antibodies) is a peer-reviewed open-access journal on monoclonal antibody research and therapeutics, launched January 2009 by Landes Bioscience, published by Taylor & Francis since 2015, edited by Janice M. Reichert, ISSN 1942-0862.

Maftivimab

Maftivimab (REGN3479) is a fully human monoclonal antibody against Zaire ebolavirus glycoprotein GP2 fusion loop, a component of the Inmazeb cocktail (with atoltivimab and odesivimab), FDA-approved 2020 and WHO-prequalified 2023.

Magrolimab

Magrolimab (Hu5F9-G4, 5F9, GS-4721, ONO-7913) is Gilead's humanized anti-CD47 IgG4 monoclonal antibody for AML and MDS; phase 3 ENHANCE and ENHANCE-3 failed, and development in blood cancers was discontinued in 2024.

MajesTEC-1 trial (NCT03145181)

MajesTEC-1 (NCT03145181/NCT04557098), a phase 1/2 single-arm trial of teclistamab (Tecvayli), a BCMA×CD3 bispecific antibody, in relapsed/refractory multiple myeloma; 165 patients at 1.5 mg/kg weekly subcutaneous dosing achieved 63% ORR, supporting the 2022 FDA accelerated approval.

Manfidokimab

Manfidokimab (AK120) is Akeso's anti-IL-4Rα monoclonal antibody for moderate-to-severe atopic dermatitis; its Phase III met endpoints in August 2025 and its NMPA NDA was accepted in February 2026.

Margetuximab

Margetuximab, sold as Margenza, is an Fc-engineered monoclonal antibody against HER2 developed by MacroGenics, approved in the US in 2020 with chemotherapy for HER2-positive metastatic breast cancer.

Marnetegragene autotemcel

Marnetegragene autotemcel (KRESLADI, marne-cel, formerly RP-L201) is Rocket Pharmaceuticals' autologous lentiviral gene therapy adding ITGB2 copies; FDA accelerated approval March 26, 2026 for pediatric severe LAD-I.

Marstacimab

Marstacimab (HYMPAVZI, marstacimab-hncq) is Pfizer's anti-TFPI IgG1 monoclonal antibody, approved by the FDA in 2024 and expanded in 2026, for weekly subcutaneous prophylaxis in hemophilia A or B with or without inhibitors.

Mecasermin rinfabate

Mecasermin rinfabate (iPlex, SomatoKine) is a recombinant 1:1 IGF-I/IGFBP-3 protein complex for severe primary IGF-1 deficiency; FDA approved December 2005, withdrawn 2007 after a patent settlement.

Mepolizumab

Mepolizumab (Nucala) is GlaxoSmithKline's humanized anti-IL-5 IgG1 kappa monoclonal antibody, first FDA-approved November 2015 for severe eosinophilic asthma; 100 mg subcutaneously every 4 weeks, halving exacerbations, with later indications in CRSwNP, COPD, EGPA, and HES.

Mesenchymal stromal cell therapy

Mesenchymal stromal cell (MSC) therapy is a cell-based treatment that uses stromal cells from bone marrow, adipose tissue, or umbilical cord to dampen inflammation and support tissue repair.

Mevonlerbart

Mevonlerbart (REGN1909) is a fully human monoclonal antibody from Regeneron that binds Fel d 1, the dominant cat allergen, and is in Phase 3 development for cat allergy.

Mifamurtide acid

Mifamurtide (L-MTP-PE, Mepact) is a synthetic NOD2-activating liposomal immunostimulant approved in the EU in 2009 for high-grade resectable non-metastatic osteosarcoma in patients aged 2 to 30.

Mirikizumab

Mirikizumab (Omvoh, mirikizumab-mrkz), Eli Lilly's humanized IgG4 antibody against IL-23 p19, treats moderate-to-severe ulcerative colitis and Crohn's disease; first approved in Japan in March 2023 and by the FDA in October 2023.

Mirvetuximab soravtansine

Mirvetuximab soravtansine (Elahere, IMGN853) is a first-in-class antibody-drug conjugate targeting folate receptor alpha, approved for FRα-positive, platinum-resistant ovarian cancer; MIRASOL showed survival benefit over chemotherapy.

Misitatug blivedotin

Misitatug blivedotin (RC88) is RemeGen's mesothelin-targeting antibody-drug conjugate, a humanized anti-MSLN IgG1 linked to MMAE via a cleavable linker, in phase 1/2 trials for ovarian, lung, and cervical cancers.

Mitumomab

Mitumomab (BEC2) is a murine anti-idiotypic monoclonal antibody cancer vaccine mimicking GD3 ganglioside, developed by ImClone Systems, Memorial Sloan-Kettering, and Merck KGaA for small cell lung cancer and melanoma; its Phase III SCLC trial failed and development was discontinued.

Mk-3415

Mk-3415 (actoxumab, CDA1/GS-CDA1) is Merck's fully human monoclonal antibody against C. difficile toxin A; it failed phase 3 MODIFY trials, its arm stopped for safety, and only bezlotoxumab (MK-6072) was approved.

Mocertatug rezetecan

HS-20089 (GSK5733584, mocertatug rezetecan) is a Hansoh-discovered, GSK-licensed B7-H4-targeted antibody-drug conjugate with a topoisomerase I inhibitor payload (DAR 6) in phase 3 trials for platinum-resistant ovarian cancer.

Modotuximab

Modotuximab (zatuximab, 1024 DS), an investigational IgG1 monoclonal antibody against EGFR that induces receptor internalization and degradation; used clinically as the Sym004 futuximab/modotuximab mixture in phase 3 colorectal cancer trials, not approved.

Mogamulizumab

Mogamulizumab (brand name Poteligeo) is a humanized monoclonal antibody against CCR4 used to treat T-cell malignancies, discovered by Kyowa Hakko Kirin and first approved in Japan in 2012.

Molgramostim

Molgramostim (Molgradex, Leucomax) is an E. coli-derived recombinant human GM-CSF, inhaled 300 µg daily for autoimmune pulmonary alveolar proteinosis; positive IMPALA and IMPALA-2 trials, not FDA-approved.

Monalizumab

Monalizumab (IPH2201), Innate Pharma's humanized IgG4 anti-NKG2A checkpoint antibody partnered with AstraZeneca; Phase II head and neck cancer response of 31% with cetuximab, but the Phase III INTERLINK-1 trial met futility.

Monoclonal antibody

Monoclonal antibodies (mAbs): identical antibodies made by hybridomas, invented by Köhler and Milstein in 1975, honored by the 1984 Nobel Prize; first therapeutic OKT3 (1986), landmark cancer drug rituximab (1997).