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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
[Trastuzumab and its biosimilars]
Tomasz Sarosiek1, Paweł Morawski1
1Department of Clinical Oncology and Chemotherapy, Magodent Hospital Elbląska in Warsaw.
Abstract:
Trastuzumab is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells overexpress HER2, a membrane-bound receptor activated by EGF family of ligands. Due to the high cost of the therapy and no refund of the drug in many countries, there is still a large group of patients who do not have the opportunity to receive trastuzumab. A biosimilar is a medical product highly similar to another already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Clinically effective biosimilars may expand patient access to trastuzumab therapy. In the coming months, European Medicines Agency (EMA) continues to increase the number of biosimilar approvals for trastuzumab, helping to promote competition that can lower therapy costs.
Insights
Biosimilar trastuzumab offers a highly similar and effective alternative to the original drug, potentially expanding patient access to HER2-positive cancer treatment. Increased biosimilar approvals are expected to lower costs and improve treatment accessibility.
Area of Science:
- Oncology
- Immunology
- Pharmacology
Background:
- Trastuzumab is a key therapy for HER2-overexpressing breast and gastric cancers.
- High treatment costs limit patient access to trastuzumab globally.
- Biosimilars offer a cost-effective, highly similar alternative to originator biologics.
Purpose of the Study:
- To evaluate the role of biosimilar trastuzumab in expanding patient access to HER2-targeted therapy.
- To highlight the regulatory standards for biosimilar approval.
- To discuss the potential impact of biosimilar competition on therapy costs.
Main Methods:
- Review of regulatory guidelines for biosimilar development and approval.
- Analysis of clinical efficacy and safety data for trastuzumab biosimilars.
- Examination of market trends and economic impact of biosimilar adoption.
Main Results:
- Biosimilars demonstrate comparable quality, safety, and efficacy to originator trastuzumab.
- Regulatory bodies like the EMA are increasing biosimilar approvals.
- Biosimilar availability is anticipated to drive competition and reduce treatment expenses.
Conclusions:
- Trastuzumab biosimilars are clinically effective and can significantly improve patient access to HER2-targeted cancer treatment.
- The expanding market of biosimilars promises to lower healthcare costs.
- Increased competition through biosimilars will enhance global availability of trastuzumab therapy.
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