Expert Opin Biol Ther. 2013 Feb;13(2):153-6. doi: 10.1517/14712598.2012.758710. Epub 2013 Jan 4.
Monoclonal antibodies (MAs) are complex biotherapeutics as their molecular mechanism of action depends on multiple domains. Consequently regulatory approval of biosimilars of MAs is subjected to specific, science-based guidelines. An extensive comparative in vitro characterization to evaluate the biosimilarity of the various functional domains is required. The exquisite species specificity of MAs precludes reliable in vivo non-clinical evaluations and means that adequately designed clinical studies are extremely critical to confirm the biosimilarity. To date no biosimilar MAs have been approved. Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.
单克隆抗体（MAs）是复杂的生物疗法，因为它们的作用机制取决于多个结构域。因此，MA 的生物类似药的监管批准需要遵循特定的、基于科学的指导方针。需要进行广泛的体外比较表征，以评估各种功能结构域的生物相似性。MA 的物种特异性非常高，排除了可靠的体内非临床评估，这意味着精心设计的临床研究对于确认生物相似性至关重要。迄今为止，尚无 MA 的生物类似药获得批准。考虑到 MA 的生物类似药预期开发成本较高，它们的使用很可能会被替代抗体形式和下一代 MA 所取代。
