Saleem Tabinda, Qurashi Hafiz, Jamali Munira, Chan Gomez Janet, Kanderi Tejaswi
Internal Medicine, University of Pittsburgh Medical Center (UPMC) Pinnacle, Harrisburg, USA.
Internal Medicine, Dow Medical College, Dow University of Health Sciences (DUHS), Karachi, PAK.
Cureus. 2020 Jul 20;12(7):e9300. doi: 10.7759/cureus.9300.
A biosimilar is a biochemical product like another already approved biologic agent, known as the reference agent. To be endorsed by the Food and Drug Administration (FDA), biosimilars must demonstrate that they are as safe and effective as their reference item, with no clinical distinction. Humanized monoclonal antibodies (mAb) are revolutionizing the treatment of gastrointestinal and gynecologic malignancies. Bevacizumab, trastuzumab, cetuximab, rituximab, and pegfilgrastim are the most widely used mAb products with oncologic indications. Due to the complexities of the regulatory system, it may take time for anti-cancer biosimilars to play a significant game-changing role. Over the last decade, the use of generics has saved billions of dollars every year, and it is expected that biosimilars will soon prove to be a cost-effective alternative and can play an important role in driving down healthcare costs globally. In this review, we provide a critical appraisal of biosimilars with an emphasis on bevacizumab-awwb (Avastin) and its clinico-pharmacologic characteristics, safety, efficacy, interchangeability, regulatory and oncologic perspectives, and overall clinical perception.
生物类似药是一种生化产品，类似于另一种已获批准的生物制剂，即参比制剂。要获得美国食品药品监督管理局（FDA）的认可，生物类似药必须证明其与参比制剂一样安全有效，不存在临床差异。人源化单克隆抗体（mAb）正在彻底改变胃肠道和妇科恶性肿瘤的治疗方式。贝伐单抗、曲妥珠单抗、西妥昔单抗、利妥昔单抗和聚乙二醇化重组人粒细胞刺激因子是最广泛使用的有肿瘤学适应证的单克隆抗体制剂。由于监管系统的复杂性，抗癌生物类似药可能需要一段时间才能发挥重大的变革性作用。在过去十年中，仿制药的使用每年节省了数十亿美元，预计生物类似药很快将被证明是一种具有成本效益的替代品，并能在降低全球医疗成本方面发挥重要作用。在本综述中，我们对生物类似药进行了批判性评估，重点关注贝伐单抗-awwb（阿瓦斯汀）及其临床药理学特征、安全性、疗效、可互换性、监管和肿瘤学观点以及总体临床认知。
