UCLA Division of Hematology-Oncology, 2020 Santa Monica Boulevard, Suite 600, Santa Monica, CA, 90404, USA.
Pfizer Inc, 235 East 42nd Street, New York, NY, 10017-5755, USA.
Target Oncol. 2017 Oct;12(5):599-610. doi: 10.1007/s11523-017-0518-1.
Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, with mortality most often attributable to metastatic disease. Bevacizumab, a humanized monoclonal antibody targeting vascular endothelial growth factor, has a significant role in the treatment of metastatic CRC (mCRC). However, patient access to bevacizumab may be limited in some regions or circumstances, owing to factors related to insurance coverage, reimbursement, patient out-of-pocket costs, or availability. As a result, outcomes for patients with mCRC may be worsened. Additionally, counterfeit bevacizumab has infiltrated legitimate supply chains, exposing patients to risk. Oncologists may also be affected detrimentally, since resolving access issues can be time-consuming and demoralizing. The imminent expiry of patents protecting bevacizumab provides other manufacturers with the opportunity to produce highly similar versions known as biosimilars. High-quality, safe, and effective biosimilars have the potential to expand access to bevacizumab. Most of the bevacizumab biosimilars currently in development are in clinical trials in patients with non-small-cell lung cancer, and future authorization for mCRC indications will, therefore, be based on extrapolation. This article reviews the current role of bevacizumab in the management of mCRC, the possible barriers associated with diminished access to bevacizumab, and the potential bevacizumab biosimilars in development. How biosimilars may impact the treatment of mCRC is also discussed.
结直肠癌(CRC)是全球肿瘤相关发病率和死亡率的主要原因,其死亡率通常归因于转移性疾病。贝伐珠单抗是一种针对血管内皮生长因子的人源化单克隆抗体,在转移性结直肠癌(mCRC)的治疗中具有重要作用。然而,由于与保险覆盖范围、报销、患者自费成本或供应可用性相关的因素,贝伐珠单抗在一些地区或情况下可能无法让患者获得。因此,mCRC 患者的治疗结果可能会恶化。此外,假冒的贝伐珠单抗已经渗透到合法的供应链中,使患者面临风险。肿瘤学家也可能受到不利影响,因为解决获取问题可能既耗时又令人沮丧。保护贝伐珠单抗的专利即将到期,这为其他制造商提供了生产高度相似的生物类似药的机会。高质量、安全且有效的生物类似药有可能扩大贝伐珠单抗的获取渠道。目前正在开发的大多数贝伐珠单抗生物类似药都在非小细胞肺癌患者的临床试验中进行,因此,mCRC 适应证的未来授权将基于外推法。本文综述了贝伐珠单抗在 mCRC 管理中的现有作用、获得贝伐珠单抗可能存在的障碍,以及正在开发的潜在贝伐珠单抗生物类似药。还讨论了生物类似药可能如何影响 mCRC 的治疗。