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我国医生对生物类似药及其临床转换的认知、态度与实践调研
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| 篇名： | 我国医生对生物类似药及其临床转换的认知、态度与实践调研 |
| TITLE： | A survey on Chinese physicians’cognition，attitudes，and practices regarding biosimilars and their clinical switching |
| 摘要： | 目的 调查我国临床医生对生物类似药及其临床转换的认知、态度与实践现状，为国内生物类似药的临床合理应用及相关政策完善提供依据。方法于2025年5－9月开展全国横断面在线问卷调查，采用配额抽样法，依据医生性别、城市级别、专业设置抽样配额，向执业医师发放问卷邀请，纳入开具过单抗类生物类似药的医生进行分析；问卷涵盖其对生物类似药熟悉程度、态度、临床转换实践及原因；采用信效度检验、离散分析、交叉表分析法处理数据。结果问卷量表信效度良好，Cronbach’sα系数＞0.7，KMO值＞0.6；共发放调研邀请2071份，回收有效问卷300份，有效回收率14.5%。75.3%的受访者开具过3～5种单抗类生物类似药；仅35.3%知晓我国尚无生物类似药转换的明确监管规定；分别有46.3%、47.3%的受访者认为生物类似药与原研药的安全性、疗效无差异；63.0%的受访者担忧原研药与生物类似药长期转换存在免疫原性风险。92.3%的受访者有生物类似药转换经验，87.7%为原研药向生物类似药转换，28.2%的受访者曾对同一患者完成≥3次转换；转换的首要原因中非医疗因素占比57.4%，高于医疗因素的42.6%“，转换后治疗成本更低”为最主要的转换原因；95.3%的受访者认为转换前应当取得患者知情同意。结论受访医生对生物类似药具备基础认知，但对国家药监部门相关监管法规理解不足；尽管多数医生顾虑非医疗转换风险，临床转换却多由非医疗因素驱动。建议加强医务人员政策宣教，规范临床转换行为；国家药品监督管理局也应尽快完善生物类似药可互换性审评标准与上市后监管体系，以促进生物类似药合理使用。 |
| ABSTRACT： | OBJECTIVE To investigate the cognition， attitudes， and current practices of Chinese physicians regarding biosimilars and their clinical switching， so as to provide a basis for the rational clinical application of biosimilars in China and the improvement of related policies.METHODS A national cross-sectional online questionnaire survey was conducted in 2025. Quota sampling was adopted， with quotas based on physicians’ sex， city tier， and specialty. Questionnaire invitations were distributed to licensed physicians， and physicians who had prescribed monoclonal antibody biosimilars were included for analysis. The questionnaire covered their familiarity with biosimilars， attitudes， clinical switching practices， and reasons. Data were processed using reliability and validity tests， dispersion analysis， and cross-tabulation analysis.RESULTS The questionnaire scale showed good reliability and validity， with Cronbach’s α coefficient ＞0.7 and KMO value ＞0.6. A total of 2 071 survey invitations were distributed， and 300 valid questionnaires were returned， with an effective response rate of 14.5%. Among the respondents， 75.3% had prescribed 3-5 types of monoclonal antibody biosimilars； only 35.3% were aware that China currently has no clear regulatory provisions on biosimilar switching； 46.3% and 47.3% of respondents believed that there was no difference in safety and efficacy， respectively， between biosimilars and originator products； 63.0% of respondents were concerned about the immunogenicity risk of long-term switching between originator drugs and biosimilars. A total of 92.3% of respondents had experience with biosimilar switching， 87.7% of which involved switching from originator products to biosimilars， and 28.2% of respondents had completed three or more switches in the same patient. Among the primary reasons for switching， non-medical factors accounted for 57.4%， higher than medical factors at 42.6%； “lower treatment cost after switching” was the most important reason for switching； 95.3% of respondents believed that informed consent should be obtained from patients before switching.CONCLUSIONS The surveyed physicians had basic knowledge of biosimilars， but their understanding of the relevant regulations of the national drug regulatory authority was insufficient. Although most physicians were concerned about the risks of non-medical switching， clinical switching was mostly driven by non-medical factors. It is recommended to strengthen policy education for medical professionals and standardize clinical switching behavior. The National Medical Products Administration should also promptly improve the interchangeability review standards and post-marketing surveillance system for biosimilars, so as to promote the rational use of biosimilars. |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 高立烊；左莉娟；彭慧婷；许微欣；张莉；陈海生；时静 |
| AUTHORS： | GAO Liyang，ZUO Lijuan，PENG Huiting，XU Weixin，ZHANG Li，CHEN Haisheng，SHI Jing |
| 关键字： | 生物类似药;转换;认知;态度;监管;问卷调查 |
| KEYWORDS： | Biosimilars;switching;Cognition;attitudes;drug regulation;Questionnaire survey |
| 阅读数： | 1 次 |
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