文章来源：Julia法规翻译
FDA ReleasesaFinalQ&AGuidance for IndustryonBiosimilarDevelopment and the BPCI Act
FDA 发布 生物仿制药开发和 BPCI 法案 行业指南问答终稿
FDAisissuingafinalguidance with questions and answers(Q&As)related to development andlicensure of biosimilarand interchangeablebiosimilarproducts:“Questions and Answers on Biosimilar Development and the BPCI Act.”This guidance revises the final guidance “Questions and Answers on Biosimilar Development and the BPCI Act”(December 2018), including by finalizing Q&As that were described in the draft guidance“New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)”(December 2018). The objective of this guidance is to provide rapid, development-related guidance to biosimilarand interchangeablebiosimilarsponsors and other stakeholders on discrete issues and FDA regularly updates the guidance with Q&As as they are identified and finalized.
FDA 正在发布与生物仿制药和可互换生物仿制药产品的开发和许可相关的问答 (Q&A)的最终指南：“关于生物仿制药开发和 BPCI 法案的问答”。本指南修订了最终指南“关于生物仿制药开发和 BPCI 法案的问答”（2018 年 12 月），包括完成了指南草案“关于生物仿制药开发和 BPCI 法案的新的和修订的问答草案（修订版 2）中描述的问答”。)”（2018 年 12 月）。本指南的目的是就可自由裁量的问题向生物仿制药和可互换生物仿制药申办者和其他利益相关者提供快速、与开发相关的指导，FDA 会在发现和定稿时定期更新该指南。
This guidance finalizes Q&As on topics of importance to biosimilarand interchangeablebiosimilarproductdevelopers, such as the submission of a supplement to an approved application for a biosimilar, including the nature and type of information a sponsor should provide to support a post-approval manufacturing change for a licensed biosimilaror interchangeable biosimilar.
本指南最终确定了对生物仿制药和可互换生物仿制药开发商重要主题的问答，例如提交对生物仿制药批准申请的补充，包括申办者应提供的信息的性质和类型，以支持获得许可的生物仿制药或可互换的生物仿制药的批准后生产变更。
FDA is also releasing the draft guidance:“New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).”This draft guidanceretainsQ.I.12from the previous version of the draft guidance,and thisdraftQ&Aaddresses how an applicant can demonstrate that its proposed injectable biosimilar product or proposed injectable interchangeablebiosimilarproduct has the same “strength” as the reference product.
FDA 还发布了指南草案：“关于生物仿制药开发和 BPCI 法案（修订版 3）的新的和修订的问答草案。”本指南草案保留了之前版本指南草案的 Q.I.12，本问答草案解决了申请人如何证明其提议的注射用生物仿制药产品或提议的注射用可互换生物仿制药产品与参比制剂具有相同的“剂量”。
These Q&A guidance documents are part of a series of guidance documents that FDA has developed to facilitate development of biosimilar and interchangeablebiosimilarproducts andthey areanother step we‘re taking toprovide increased regulatory certaintyand predictabilityforstakeholders.
这些问答指导文件是 FDA 为促进生物仿制药和可互换生物仿制药产品的开发而制定的一系列指导文件的一部分，它们是我们为利益相关者提供更高的监管确定性和可预测性而采取的另一个步骤。
Increased competition from biosimilar and interchangeablebiosimilarproducts can help bring down the costs of biological products, improving patient access to important therapies.
来自生物仿制药和可互换生物仿制药产品的竞争加剧有助于降低生物产品的成本，改善患者获得重要疗法的机会。、
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