FDA在审批上市新抗体药物及生物类似药方面的进展

Advances of FDA in approval of the new antibody drugs and biosimilars

美国是生物技术产品的主要市场,FDA具备适当审查和批准生物类似药物申请所需的专业知识和经验。本文综述了FDA在2014年审批上市新抗体药物及生物类似药方面的进展,并且对CFDA面对新抗体药物及生物类似药物不断涌现的局势,鼓励新抗体药物及生物类似药物研发和申请提出建议。关于生物类似药物在美国的审批,FDA基于对科学以及审查员经验和专业知识的信心,一定程度地减免部分临床研究,这将给研发主体带来信心,并且在保证药品安全有效、质量可控的前提下增加了药物的可及性。

The United States is the major market for the biotechnology products,and FDA has the proper expertise and experiences for reviewing and approval of biosimilars. This paper reviewed the progresses for the new antibody drugs and biosimilars approved by FDA in 2014,and gave some recommendations for encouraging drug development and applications with facing emergence of the new antibody drug and biosimilars. Based on the confidences of science,investigators,and expertise,FDA partly relieves some clinical studies to some extent about biosimilars approvals,which would bring confidence to the manufacturers and increase accessibility of drugs on the premise of safety and quality control.