edgepedia

Biologics, monoclonal antibodies, and biosimilars

743 articles

Enzyme Replacement Therapy

Enzyme replacement therapy (ERT) administers a missing enzyme, first for Gaucher disease in 1991, later Pompe, Fabry, MPS, alpha-mannosidosis, cTTP (Adzynma), and pancreatic insufficiency; limited by blood-brain barrier and antibodies.

Epcoritamab regimen

The Epcoritamab regimen (Epkinly, Tepkinly) treats relapsed or refractory B-cell lymphoma with a subcutaneous CD3×CD20 bispecific antibody that engages T cells to kill lymphoma cells, FDA approved in 2023.

Eplontersen

Eplontersen (Wainua, Wainzua) is a GalNAc-conjugated antisense oligonucleotide silencing liver TTR mRNA, FDA-approved December 2023 at 45 mg monthly subcutaneously for hereditary transthyretin amyloidosis polyneuropathy; its ATTR-CM trial failed.

Epoetin beta

Epoetin beta (Recormon, NeoRecormon) is a recombinant human erythropoietin made in CHO cells, approved in Europe in 1990 by Boehringer Mannheim and reformulated by Roche in 1997, used for renal and cancer anemia; not US-approved.

Epoetin delta

Epoetin delta (Dynepo) was the only epoetin made in a human cell line (HT-1080), EU-approved 18 March 2002 for anemia of chronic renal failure in adults and withdrawn 17 March 2009 for commercial reasons.

Epoetin theta

Epoetin theta (Eporatio, Biopoin) is a CHO-cell recombinant human erythropoietin approved by EMA in 2009 for symptomatic anemia in adults with chronic renal failure or non-myeloid cancer on chemotherapy, dosed 20,000 IU weekly.

Epoetin zeta

Epoetin zeta (Retacrit, Silapo; US name epoetin alfa-epbx) is a biosimilar recombinant human erythropoietin made in CHO cells, EU-authorized 18 December 2007 against epoetin alfa (Eprex/Erypo) and FDA-approved 2018, used for renal, chemotherapy-related, and surgical anemia.

Epratuzumab

Epratuzumab (AMG 412, hLL2, LymphoCide) is a humanized anti-CD22 IgG1 monoclonal antibody with partial B-cell depletion, tested in SLE through phase III EMBODY trials, which failed, leaving it unapproved.

Eptacog alfa (activated)

Eptacog alfa (activated), brand NovoSeven/NovoSeven RT (Novo Nordisk), is recombinant activated factor VIIa, a bypassing agent for bleeding in hemophilia with inhibitors, factor VII deficiency, and Glanzmann's thrombasthenia; EU/US approvals 1996/1999, EU shortages through 2025.

Eptinezumab

Eptinezumab (Vyepti, ALD403, eptinezumab-jjmr) is a humanized anti-CGRP monoclonal antibody given as a 100 or 300 mg intravenous infusion every 12 weeks to prevent migraine in adults; FDA approved February 2020, developed by Alder and acquired by Lundbeck.

Equecabtagene autoleucel

Equecabtagene autoleucel (伊基奥仑赛, Fucaso) is a fully human BCMA-directed autologous CAR-T therapy by IASO Bio, conditionally approved by China's NMPA on June 30, 2023 for relapsed/refractory multiple myeloma after at least three prior lines.

Erfonrilimab

Erfonrilimab (KN046, 依瑞利单抗), a PD-L1 x CTLA-4 bispecific antibody from Jiangsu Alphamab, in phase III trials (ENREACH-L-01 squamous NSCLC, ENREACH-PDAC-01 pancreatic cancer); phase II ORR 46% in first-line metastatic NSCLC.

Ersodetug

Ersodetug (RZ358, XOMA 358) is Rezolute's investigational fully human IgG2 monoclonal antibody, a negative allosteric modulator of the insulin receptor, in Phase 3 trials for congenital and tumor hyperinsulinism hypoglycemia; not yet approved.

Erythropoietin

Erythropoietin (EPO), also called Hemopoietin, is a hormone produced mainly by the kidney that prompts red blood cell production; its recombinant forms treat anemia of chronic kidney disease.

Etanercept

Etanercept (Enbrel), a p75 TNF receptor-Fc fusion protein and first FDA-approved Fc-fusion drug (1998), blocks TNF-α and TNF-β for RA, PsA, AS, psoriasis, and JIA, with biosimilars Erelzi and Eticovo.

Etentamig

Etentamig (ABBV-383, formerly TNB-383B) is AbbVie's investigational BCMA x CD3 bispecific T-cell engager for multiple myeloma and AL amyloidosis; its Phase 3 CERVINO trial reported 74% ORR and PFS hazard ratio 0.40 versus standard therapies.

Etesevimab

Etesevimab (JS016, LY-CoV016, CB6) is a human IgG1 monoclonal antibody against the SARS-CoV-2 spike RBD, developed by Junshi Biosciences and IMCAS with Eli Lilly, authorized with bamlanivimab for COVID-19 and revoked in 2023 over resistant variants.

Etirinotecan pegol

Etirinotecan pegol (NKTR-102, brand name Onzeald) is an investigational, long-acting PEGylated conjugate of the topoisomerase I inhibitor irinotecan, designed to release irinotecan slowly for sustained tumor exposure.

Etranacogene dezaparvovec drlb

Etranacogene dezaparvovec drlb (HEMGENIX) is an AAV5-based gene therapy by CSL Behring, approved in 2022 as a single infusion to treat hemophilia B in adults.

Etrolizumab

Etrolizumab (rhuMAb beta7, PRO145223) is a Roche humanized anti-beta7 monoclonal antibody targeting alpha4beta7 and alphaEbeta7 integrins for IBD; its phase 3 program failed key endpoints and it was not approved.

Etuvetidigene autotemcel

Etuvetidigene autotemcel (Waskyra, etu-cel) is an autologous lentiviral HSPC gene therapy for Wiskott-Aldrich syndrome, approved by FDA December 9, 2025 and EMA January 9, 2026, marketed by Fondazione Telethon.

Evinacumab

Evinacumab (Evkeeza), an ANGPTL3-inhibiting IgG4 monoclonal antibody by Regeneron, FDA-approved February 2021, lowers LDL-C via an LDL receptor-independent mechanism in homozygous familial hypercholesterolemia.

Exagamglogene autotemcel

Exagamglogene autotemcel (Casgevy, exa-cel) is Vertex Pharmaceuticals' CRISPR/Cas9-edited autologous stem cell gene therapy for sickle cell disease and beta-thalassemia, first authorized by the UK MHRA in November 2023.

Exosome therapy

Exosome therapy administers nanosized vesicles, usually from mesenchymal stromal cells, to deliver regenerative proteins and microRNAs to injured tissue; none is approved as of 2026.

Expanded Activated Lymphocytes (EAL)

Expanded Activated Lymphocytes (EAL, 扩增活化的淋巴细胞, 爱可仑赛注射液) is Beijing Yongtai's autologous non-gene-modified CIK-type T-cell immunotherapy for preventing hepatocellular carcinoma recurrence after resection; CDE breakthrough therapy 2023, conditional marketing application accepted 2025.

Ezabenlimab

Ezabenlimab (BI 754091) is a humanized IgG4 kappa anti-PD-1 monoclonal antibody from Boehringer Ingelheim that blocks PD-1 binding to PD-L1 and PD-L2; Phase I trials set a 240 mg Q3W dose with 16.2% response rate in solid tumors.

Faricimab

Faricimab (Vabysmo) is a bispecific VEGF-A/Ang-2 antibody eye injection approved 2022 for wet AMD and diabetic macular edema, and 2023 for retinal vein occlusion, with dosing up to every 16 weeks.

Farletuzumab

Farletuzumab (MORAb-003) is a humanized IgG1 monoclonal antibody against folate receptor alpha for ovarian cancer; its phase III trials missed PFS endpoints, and it now anchors the ADC farletuzumab ecteribulin (MORAb-202).

Fasinumab

Fasinumab (REGN475, SAR164877, MT-5547) is a fully human IgG4 anti-nerve growth factor monoclonal antibody developed by Regeneron with Teva and MTPC for osteoarthritis and chronic low back pain; effective in phase 3 trials but discontinued in 2022 over dose-dependent joint damage risk.

Favezelimab

Favezelimab (MK-4280), Merck's humanized anti-LAG-3 IgG4 antibody, was tested with pembrolizumab (MK-4280A) in colorectal cancer and Hodgkin lymphoma; development was discontinued in December 2024 after phase 3 KEYFORM-007 missed overall survival.