Drug intelligence / Profile preview

Bmab3000

Development stage
Phase 1
Lead developer
Viatris
Modality
Therapeutic Enzymes → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

Bmab3000 is a biosimilar candidate for Herceptin Hylecta, a fixed-dose combination of trastuzumab and recombinant human hyaluronidase PH20. Trastuzumab is a humanized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2), inhibiting tumor cell proliferation and mediating antibody-dependent cellular cytotoxicity (ADCC). The hyaluronidase component is an enzyme that temporarily depolymerizes hyaluronan in the subcutaneous extracellular matrix, increasing tissue permeability and allowing for the subcutaneous administration of large volumes of trastuzumab. Developed by Biocon Biologics in collaboration with Mylan (now Viatris), Bmab3000 is intended for the treatment of HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma, providing a more convenient delivery alternative to intravenous formulations.

Other names
trastuzumab and hyaluronidase biosimilar
02

Targets

C1Q (Complement C1q)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)ERBB2 (Erb-b2 receptor tyrosine kinase 2)FCGRT (Neonatal crystallizable fragment receptor)

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