PDF(Pubmed)
Abstract：
Biosimilars are biological drugs created from living organisms or that contain living components. They share an identical amino-acid sequence and immunogenicity. These drugs are considered to be cost-effective and are utilized in the treatment of cancer and other endocrine disorders. The primary aim of biosimilars is to predict biosimilarity, efficacy, and treatment costs; they are approved by the Food and Drug Administration (FDA) and have no clinical implications. They involve analytical studies to understand the similarities and dissimilarities. A biosimilar manufacturer sets up FDA-approved reference products to evaluate biosimilarity. The contribution of next-generation sequencing is evolving to study the organ tumor and its progression with its impactful therapeutic approach on cancer patients to showcase and target rare mutations. The study shall help to understand the future perspectives of biosimilars for use in gastro-entero-logic diseases, colorectal cancer, and thyroid cancer. They also help target specific organs with essential mutational categories and drug prototypes in clinical practices with blood and liquid biopsy, cell treatment, gene therapy, recombinant therapeutic proteins, and personalized medications. Biosimilar derivatives such as monoclonal antibodies like trastuzumab and rituximab are common drugs used in cancer therapy. Escherichia coli produces more than six antibodies or antibody-derived proteins to treat cancer such as filgrastim, epoetin alfa, and so on.
摘要：
生物仿制药是从活生物体产生的或含有活成分的生物药物。它们具有相同的氨基酸序列和免疫原性。这些药物被认为是具有成本效益的,并且用于治疗癌症和其他内分泌紊乱。生物仿制药的主要目的是预测生物相似性，功效,和治疗费用；它们已获得食品和药物管理局（FDA）的批准，没有临床意义。它们涉及分析研究，以了解相似性和差异性。一家生物仿制药制造商建立了FDA批准的参考产品来评估生物相似性。下一代测序的贡献正在演变为研究器官肿瘤及其进展，其对癌症患者有影响力的治疗方法，以展示和靶向罕见突变。这项研究将有助于了解生物仿制药在胃肠道疾病中的未来前景，结直肠癌,和甲状腺癌。它们还有助于在临床实践中通过血液和液体活检靶向具有基本突变类别和药物原型的特定器官，细胞治疗,基因治疗,重组治疗性蛋白质，和个性化的药物。生物类似物衍生物如单克隆抗体如曲妥珠单抗和利妥昔单抗是用于癌症治疗的常见药物。大肠杆菌产生超过六种抗体或抗体衍生的蛋白质来治疗癌症，例如非格司亭，epoetinalfa,等等。
