Biosimilar in Breast Cancer: A Narrative Review.

ABSTRACT

Breast cancer (BC) has been identified as a major public health cancer as it topped the list of most prevalent cancers among women in the last three years. Rigorous research has been conducted to improve the prognosis of cancer therapies since the time of inception. Recent advancements in cancer therapy have introduced monoclonal biosimilars as a promising treatment alternative. Monoclonal antibodies (mAbs), produced through cloning, have demonstrated effectiveness in targeting diverse antigens. Biosimilar, considered complex entities compared to small-molecule drugs, pose challenges in replication due to their biological nature. The manufacturing process involves rigorous comparability testing to ensure similarity in quality, safety, and efficacy with the reference product. Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. The implications of monoclonal biosimilars extend beyond trastuzumab, with bevacizumab emerging as another significant biosimilar for BC treatment. The shift toward biosimilar aims to enhance accessibility to biologics by reducing costs. Health economic analyses indicate potential cost savings, contributing to the overall cost-effectiveness of biosimilar adoption. While concerns about switching between reference products and biosimilars exist, evidence suggests a lower risk of immunogenicity-related side effects with mAbs like trastuzumab. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare.