Full
Outline
The aim of this article is to make some suggestions for the regulations on interchangeability and clinical drug switching of biosimilar in China. Literature and relevant policies were reviewed. The development status of biosimilars in China was summarized, the regulatory experiences on the interchangeability of biosimilars in the United State and European Union were combed, and research findings on clinical drug switching were analyzed as well. Biosimilars have developed rapidly in China, but the related regulatory system has not been completely established. The United States and European Union have already initially established the management of biosimilar interchangeability, while the practical experience and clinical evidence are limited, and expert consensus has not been reached. There are still potential risks and concerns on switching from an originator biologic to a biosimilar or from one biosimilar to another. Drug regulatory authority should pay more attention to drug safety, clinical data information transparency, and technical guidelines on interchangeability, drug traceability, and incentive system.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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