Cancer Discov. 2018 Oct;8(10):1200. doi: 10.1158/2159-8290.CD-NB2018-113. Epub 2018 Aug 28.
The FDA has approved 12 biosimilar products, including two cancer treatments, yet biosimilars face obstacles in entering the market. The FDA Biosimilars Action Plan outlines steps the agency is taking to facilitate competitiveness of biosimilars, including improving the efficiency of the review process and educating health care professionals about the therapies.
美国食品药品监督管理局(FDA)已批准了12种生物类似药产品,其中包括两种癌症治疗药物,但生物类似药在进入市场时面临障碍。FDA生物类似药行动计划概述了该机构为促进生物类似药的竞争力而采取的步骤,包括提高审评流程的效率以及对医疗保健专业人员进行有关这些疗法的教育。