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With the expiration of the patent of denosumab (Prolia^®/Xgeva^®) and its marketing in China, the number of denosumab biosimilars developed by domestic biological enterprises according to the path of biosimilars is gradually increasing. This paper reviews the domestic and foreign registration and research status of the original drug and biosimilars, clarifies the challenges and technical requirements in the similarity evaluation of denosumab, analyzes and discusses the common problems in the pharmaceutical evaluation of denosumab biosimilars in combination with the review practice, in order to provide a basis for the pharmaceutical development and evaluation of denosumab biosimilars.

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随着地舒单抗原研药（Prolia^®/Xgeva^®）专利到期及原研药在我国上市，国内生物医药企业按照生物类似药路径开发的地舒单抗生物类似药逐渐增多。本文梳理了地舒单抗原研药及生物类似药国内外注册与研发现状，分析了地舒单抗相似性评价中的挑战及技术要求，结合审评实践对地舒单抗生物类似药的药学评价中常见问题进行分析探讨，以期为此类生物类似药的药学开发与评价提供帮助。

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阚红金，女，硕士，审评员，主要从事生物制品药学审评工作。联系电话：(010)80996157，E-mail: kanhj@cde.org.cn。

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阚红金，女，硕士，审评员，主要从事生物制品药学审评工作。联系电话：(010)80996157，E-mail: kanhj@cde.org.cn。

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