Trastuzumab biosimilar is under clinical development by Accord Healthcare and currently in Pre-Registration for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Pre-Registration drugs for Human Epidermal Growth Factor Receptor 2 Negative 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.

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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 (Zercepac/ Han Qu You, Trastucip, Tuzucip) is a humanized IgG1 kappa monoclonal antibody. It is formulated as lyophilized powder for concentrate for solution for intravenous route of administration. Zercepac is indicated for the treatment of HER2 positive metastatic breast cancer, HER2 positive early breast cancer, HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction and metastatic gastric cancer.

Trastuzumab is under development for the adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

Accord Healthcare overview

Accord Healthcare, a subsidiary of Intas Pharmaceuticals Ltd, is a manufacturer of generic pharmaceuticals. The company supplies its products in orals, injectables, and molecules. The company’s products include Acetazolamide ER Capsules, Allopurinol Tablets, Amitriptyline Hydrochloride Tablets, Bendamustine Lyophilized Injections, Buspirone Tablets, Capecitabine Tablets, Dimethyl Fumarate DR Capsules, Clonazepam Tablets, Clozapine Tablets, Decitabine Injection, Entecavir Tablets, Fingolimod Capsules, Diltiazem XR Capsules, Pirfenidone Tablets, Glimepiride Tablets, Letrozole Tablets, Mitomycin Injection, Ropinirole Tablets, Naltrexone Hydrochloride Tablets, Olmesartan Tablets, Rosuvastatin Tablets, Paricalcitol Injection, Succinylcholine Chloride, Tacrolimus Capsules, Tacrolimus Ointment, and Zoledronic Acid Injection. Accord Healthcare is headquartered in North Carolina, the US.

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

This content was updated on 22 January 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.