RESUMEN
Monoclonal antibodies are highly complex, large and biologic products with a substantial impact on the clinical management of a variety of diseases including cancer. The expiry of patents for essential monoclonal antibodies in cancer care such as bevacizumab, rituximab and trastuzumab, has prompted the global development of biosimilars to balance the biologics market. However, an understanding of the different approach of biosimilar development compared with its reference medicinal product, especially in the context of clinical trial design and end point selection may help oncologists integrating biosimilars into clinical practice. Herein, we reviewed the clinical development of biosimilars in oncology comparing the available clinical data of proposed biosimilars of bevacizumab, rituximab and trastuzumab.
Lay abstract In the last decades, patients with cancer have been treated with novel medicines as bevacizumab, rituximab and trastuzumab produced or derived by a biologic source. The expiry of patents for these biologic medicines brings the opportunity to develop similar biologic products, known as biosimilars. However, to be authorized and commercialized, biosimilars need to demonstrate their equivalence in quality, efficacy and safety to the reference medicinal product through a complete development process. An understanding of the different approach of biosimilar development compared with its reference medicinal product especially in the context of the clinical studies trials may help oncologists integrating biosimilars into clinical practice. Herein, we reviewed the clinical development of biosimilars in oncology comparing the available clinical data of proposed biosimilars of bevacizumab, rituximab and trastuzumab.