Biosimilars in Colorectal Cancer

Biologics (BL) are complex moiety derived from living resources through biotechnology. BL are quite different compared to small molecules with respect to target specificity, better outcome in chronic diseases, and excellent immunomodulators. Biosimilars (BS) are developed once biologics (reference product) patents expire to provide affordable accessible therapy to the patients. Extremely sensitive in vitro, in vivo, and clinical trials need to be conducted to confirm the bioequivalence of BL with BS. Cancer remains a devastating disease across the globe. Out of a total of 44 BS are approved by US FDA, around 18 are used for oncotherapy. Colorectal cancer (CRC) is the second fatal cancer among others. BS can be used as mono- or adjunct therapy for the CRC. Bevacizumab-awwb was pioneer BS and has shown excellent outcome in metastatic CRC. The epoetin alfa-epbx and pegfilgrastim-jmdb used to ameliorate bone marrow suppression induced by chemotherapy. Other important BS used in CRC oncotherapy include trastuzumab-dkst, tocilizumab-bavi, adalimumab-aaty, and cetuxa. Multiple meta-analysis studies of randomized clinical trials indicated that BS are equivalent in efficacy to their reference products. Anyhow stringent regulatory screening and pharmacovigilance with patients’ acceptance are necessary to ensure incorporation of BS in oncotherapeutics. Many challenges need to be addressed like patient recruitments, market competitions, interchangeability by pharmacist, nomenclature, production, and approval timeline to make successful use of BS in the future. This chapter highlights typical characteristics of BS, pharmacology requirement of BS to be effective in CRC, regulatory guidelines, manufacturing process, current BS for CRC, ongoing clinical trials of BS, and future of BS.