[关键词]
[摘要]
美国食品药品管理局(FDA)于2020年2月发布了"供企业用处方生物参照药和生物类似药的促销说明书和广告考虑的问题问答指导原则"(草案)。该指导原则主要介绍FDA对生物类似药促销资料的撰写要求,而我国目前尚无类似指导原则。值此我国生物类似药研制正在兴起阶段,详细介绍该指导原则,期望对这类新兴药物促销资料的撰写和监管有帮助,以确保其真实而无误导性。
[Key word]
[Abstract]
FDA issued the Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry (draft) in February 2020. This guidance mainly introduces the FDA's requirements for writing promotional materials of biosimilar products. At present there is no similar guidance in China.Just as the development of biosimilar products in China is in the rising stage, the guidance are introduced in detail, hoping to be helpful for the writing and supervision of the promotional materials of such new products, so as to ensure that they are true and not misleading.
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