Kaushik V V
Apollo Hospital, Chennai, Tamil Nadu.
J Assoc Physicians India. 2017 May;65(5 Suppl):15-21.
A first fully humanized monoclonal antibody approved by US Food and Drug Administration (FDA) in 2002 was Adalimumab. Clinical efficacy and safety of adalimumab has been assessed in various trials in rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis. It is one of the major sales success among biological and still one of the greatest blockbuster amongst monoclonal antibodies. With the advent of patent expiry of the parent drug HUMIRA, several potential biosimilars have debuted in various markets worldwide. Present article will discuss current situation of molecules that are front-runners to become adalimumab biosimilars with particular stress on Indian market and ZRC3197 (Adalimumab Biosimilar).
2002年美国食品药品监督管理局（FDA）批准的首个完全人源化单克隆抗体是阿达木单抗。已在类风湿性关节炎、强直性脊柱炎、银屑病、银屑病关节炎、克罗恩病和溃疡性结肠炎的各种试验中评估了阿达木单抗的临床疗效和安全性。它是生物制品中主要的销售成功产品之一，并且仍然是单克隆抗体中最畅销的产品之一。随着原研药修美乐专利到期，几种潜在的生物类似药已在全球各个市场亮相。本文将讨论有望成为阿达木单抗生物类似药的分子的现状，特别关注印度市场和ZRC3197（阿达木单抗生物类似药）。
