Drug intelligence / Profile preview

BP58

Development stage
Preclinical
Lead developer
CuraTeQ Biologics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

BP58 is a subcutaneous (S.C.) biosimilar formulation of trastuzumab being developed by CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, for the treatment of HER2-positive cancers, including breast cancer. It is designed as a biosimilar to subcutaneous trastuzumab (Herceptin SC / Herceptin Hylecta), which co-formulates the anti-HER2 monoclonal antibody trastuzumab with recombinant human hyaluronidase (rHuPH20) to facilitate subcutaneous administration and reduce infusion time. BP58 is currently in preclinical development (CMC development) and is projected to enter clinical trials in 2026.

Other names
trastuzumab S.C.trastuzumab subcutaneous
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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