Hadavand Naser, Valadkhani Mahboubeh, Zarbakhsh Aida
National Drug Selection Council Secretariat, Pharmaceutical and Narcotic Affairs Department, Food and Drugs Organization, Ministry of Health and Medical Education, Fakhr-e-Razi Street, Enghlab Avenue, Tehran, Iran.
Biologicals. 2011 Sep;39(5):325-7. doi: 10.1016/j.biologicals.2011.06.019. Epub 2011 Aug 27.
With the expiration of patents on the first generation of rDNA biopharmaceuticals, competitors began to introduce biosimilar products. The concept of generics as applied to classical chemical drugs cannot be used for biotechnology products. Physicochemical characterization, bioassays and animal studies do not have the ability to predict reliably the safety and efficacy of biotherapeutics. Clinical studies are always necessary. While regulators all over the world were really in need of a comprehensive guideline in this area, WHO introduced a guideline which is principally a basis for regulating biosimilars and is applicable in Iran, as well as many other countries.
随着第一代重组DNA生物制药专利的到期，竞争对手开始推出生物类似药产品。适用于传统化学药物的仿制药概念不适用于生物技术产品。物理化学特性分析、生物测定和动物研究无法可靠地预测生物治疗药物的安全性和有效性。临床研究始终是必要的。当世界各地的监管机构确实急需该领域的全面指南时，世界卫生组织出台了一项指南，该指南主要作为监管生物类似药的基础，适用于伊朗以及许多其他国家。
