Analysis on the Policy Measures of Clinical Use Incentives and Risk Control for Biosimilars in the European Union / 中国药学杂志

ABSTRACT

OBJECTIVE: The supervision of biosimilars in EU is based on scientific and reasonable principles. It not only had lots of laws, regulations and policy guidelines on marketing approval, but also made great efforts in clinical use and risk monitoring. To provide reference for the supervision and management of biosimilars in China. METHODS: Through the data summary and system comparison, the article described and analyzed the clinical use incentives and post-marketing risk control policies of biosimilars in EU countries. RESULTS: It is found that under the background of perfecting the regulatory systems and policies, EU countries encourage the vigorous development of the biosimilar industry and strictly control the drugs' safety, effectiveness and clinical risks. CONCLUSION: China could learn from the EU experience, encourage the development of biosimilars by improving pricing, reimbursement, clinical substitution and other policies. At the same time, we should also pay attention to the specificity of biosimilars, ensure that clinical risks are controllable and drugs are safe and effective.