Goyal Parag, Vats Bhavesh, Subbarao Malini, Honnappa Chethan Gejjalagere, Kabadi Pradeep, Rohil Sheija, Bera Arnab, Mehta Gaurav R, Pai Harish, Adhikari Laxmi, Tagore Ranitendranath, Sharma Shulagna, Venkatachala Roopa, Nair Pradip, Annegowda Shankara, Sahu Abhilashi, Trivedi Sneha, Shastri Namrata, Gokhale Yatika, Thomas Roshni, Thakur Anushikha, Mohan Deepa, Rao K Umamaheshwara, Melarkode Ramakrishnan, Ullanat Rajesh
Biologics R&D, Viatris Inc, Canonsburg, PA, USA.
Biologics R&D, Viatris Inc, Hyderabad, India.
Expert Opin Biol Ther. 2022 Feb;22(2):271-298. doi: 10.1080/14712598.2021.1973426. Epub 2021 Oct 13.
Bevacizumab (BEV) is a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to vascular endothelial growth factor (VEGF)-A and acts as an antiangiogenic agent. It is approved for treatment of many cancer indications, including metastatic colorectal cancer and nonsquamous non-small cell lung cancer.
The analytical similarity of the BEV biosimilar MYL-1402O to reference BEV sourced from the European Union and United States was assessed using physicochemical and functional tests to support the clinical development of MYL-1402O. Assessment of physicochemical and analytical similarity showed that MYL-1402O has the same amino acid sequence and similar posttranslational modification profile as the reference BEV products.
The functional and biologic activity of MYL-1402O assessed using inhibition of VEGF-induced cell proliferation in human umbilical vein endothelial cells, inhibition of VEGF-induced VEGF receptor 2 phosphorylation, and fragment antigen and fragment crystallizable receptor binding, was comparable to reference BEV products.
The totality of the data assessment confirms the high degree of similarity of MYL-1402O to reference BEV with respect to physicochemical and in vitro functional properties. The product quality data presented here, along with data from phase 1 clinical studies, demonstrate the similarity of MYL-1402O to reference BEV products, supporting further clinical development of this BEV biosimilar.
贝伐单抗（BEV）是一种重组人源化单克隆免疫球蛋白G1抗体，可与血管内皮生长因子（VEGF）-A结合，起到抗血管生成剂的作用。它被批准用于治疗多种癌症适应症，包括转移性结直肠癌和非鳞状非小细胞肺癌。
使用物理化学和功能测试评估了BEV生物类似药MYL-1402O与源自欧盟和美国的参比BEV的分析相似性，以支持MYL-1402O的临床开发。物理化学和分析相似性评估表明，MYL-1402O与参比BEV产品具有相同的氨基酸序列和相似的翻译后修饰谱。
使用抑制人脐静脉内皮细胞中VEGF诱导的细胞增殖、抑制VEGF诱导的VEGF受体2磷酸化以及片段抗原和可结晶片段受体结合来评估MYL-1402O的功能和生物学活性，其与参比BEV产品相当。
数据评估的总体结果证实了MYL-1402O与参比BEV在物理化学和体外功能特性方面高度相似。此处呈现的产品质量数据以及1期临床研究的数据证明了MYL-1402O与参比BEV产品的相似性，支持了这种BEV生物类似药的进一步临床开发。
