FDA发布生物类似药及可互换生物类似药上市后生产变更问答指南草案
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
FDA发布问答指南草案，说明已获批生物类似药及可互换生物类似药上市后生产变更在不同报告类别下申请人应提交的资料类型。文件编号为FDA-2024-D-2581，由CDER与CBER发布，标注为草案且不用于实施，所载建议不具约束力。公众可按21 CFR 10.115(g)(5)随时在线或邮寄提交意见。
草案以问答形式说明已获批生物类似药上市后生产变更在不同报告类别下应提交的资料类型，可供申请人对照所需材料。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2024-D-2581
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this guidance) made to licensed biosimilars and licensed interchangeable biosimilars. This question-and-answer (Q&A) guidance is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2024-D-2581.
来源：FDA Pharmaceutical Quality Documents · fda.gov