ABSTRACT

Introduction

Over the past three decades, biotherapeutics have transformed health care by offering effective treatments for complex diseases that were otherwise difficult to deal with via small molecule pharmaceuticals. Patents on several biotherapeutics have expired or are due to expire in recent times, and this has fueled the growth in biosimilars, products that are deemed to be similar to the already-approved innovator products in terms of safety and efficacy. Production of biosimilars is complicated by the fact that in biotech processes, the process is the product and there have been many instances where a small change in the manufacturing process results in significant undesirable clinical impact. This is why regulatory authorities around the world have formulated stringent guidelines for the approval of biosimilars.

Areas covered

This article aims to review unsuccessful regulatory filings for biosimilar approval.

Expert Opinion

We have focused on regulatory submissions to EMA and FDA. Key shortcomings of the filings that failed to receive approval have been identified and discussed.

中文翻译：

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生物仿制药的批准：审查不成功的监管文件。

摘要

介绍

在过去的三十年里，生物疗法通过为复杂疾病提供有效的治疗方法，改变了医疗保健，否则这些疾病很难通过小分子药物治疗。近期，一些生物治疗药物的专利已到期或即将到期，这推动了生物仿制药的增长，这些产品被认为在安全性和有效性方面与已获批准的创新产品相似。生物仿制药的生产很复杂，因为在生物技术过程中，过程就是产品，并且在许多情况下，制造过程的微小变化会导致显着的不良临床影响。这就是为什么世界各地的监管机构都制定了严格的生物仿制药批准指南。

覆盖区域

本文旨在审查不成功的生物仿制药批准监管备案。

专家意见

我们专注于向 EMA 和 FDA 提交监管申请。已确定并讨论了未能获得批准的申请的主要缺点。