ABSTRACT

Biologic therapies, such as monoclonal antibody (mAb)-based immunotherapy, are increasingly being utilized in cancer treatment due to their high specificity for the target tissue which translates to relatively fewer adverse effects and increased effectiveness compared to other available options. However, the high costs of mAb therapy limit their use and represent a barrier to more widespread patient access. Biosimilar medicines, which undergo rigorous evaluation to show there are no clinically significant differences in safety, purity and potency to the original reference product, could mitigate costs of immunotherapy and expand treatment access to patients. With the expiration of exclusivity rights, more biosimilars are being developed and can be expected to enter the market. This chapter will provide an overview of current oncological mAbs approved in the United States, focus on the available biosimilar products, and discuss future prospects in the development of biosimilars for cancer therapy.