Trastuzumab biosimilar is under clinical development by EirGenix and currently in Pre-Registration for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Pre-Registration drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Trastuzumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Trastuzumab biosimilar overview

Trastuzumab biosimilar (Herwenda) is a recombinant IgG1 kappa, humanized monoclonal antibody. It is formulated as lyophilized powder for concentrate for solution for intravenous route of administration. Herwenda is indicated for the treatment of breast cancer, metastatic breast cancer HER2 (Human Epidermal growth factor Receptor 2 protein)-positive metastatic breast cancer patients, early breast cancer, metastatic gastric cancer, adenocarcinoma of gastro-oesophageal function and metatstatic non-small cell lung cancer.

Trastuzumab biosimilar (EG-12014) is under development for the treatment of HER-2 positive breast cancer. It is administered through intravenous route. The drug candidate is in lyophilized sterile powder form. The drug acts by targeting the human epidermal growth factor receptor 2 (Her2). It was also under development for the treatment of gastric cancer and metastatic breast cancer.

EirGenix overview

EirGenix is a pharmaceutical contract development and manufacturing organization (CDMO). The company operates its business portfolio include contract development and manufacturing operation unit. Its biologic pipeline of candidates and drug product portfolio includes Trastuzumab, Pertuzumab, Conjugate, Bevacizumab, Covid-19 antigen rapid test kit, and cross reacting material (CRM) 197 carrier protein. The company service offerings include cell line development, process development, analytical and quality control, antibody-drug conjugate, cGMP manufacturing–mammalian system, and cGMP manufacturing–microbial system services. It operates with additional office in Zhubei, Taiwan. EirGenix is headquartered in New Taipei City, Taiwan.

For a complete picture of Trastuzumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.