Abstract

OPINION article Front. Pharmacol., 02 February 2022 | https://doi.org/10.3389/fphar.2022.815074

Highlights

  • A biosimilar drug contains active substances similar to the original biologic drug and is similar to the original drug in terms of quality, safety, and effectiveness, with no clinically significant differences (Center for Drug Evaluation of the National Medical Products Administration, 2015)

  • Given the uniqueness and complexity of biological products, biosimilar drugs are different from chemical generic drugs, and there are significant differences in their review and approval paths

  • In order to standardize the research and development (R&D) and the review of biosimilar drugs, more than 20 countries worldwide have formulated guidelines related to biosimilar drugs and clear approval paths for marketing them (European Medicines Agency, 2011; European Medicines Agency, 2014a; Shan et al, 2020)

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Summary

INTRODUCTION

A biosimilar drug contains active substances similar to the original biologic drug and is similar to the original drug in terms of quality, safety, and effectiveness, with no clinically significant differences (Center for Drug Evaluation of the National Medical Products Administration, 2015). Compared with their original drugs, biosimilar drugs have a price advantage, which is an important approach to improve patient drug accessibility and control medical costs (Jensen et al, 2020; Shan et al, 2020).

Rituximab Injection Rituximab Injection*
Metastatic breast cancer
Identifying Reference Drugs
Managing Labels
Extrapolating Indications
Interchangeability of Biosimilar Drugs
Creating a Catalog of Marketed Biosimilar Drugs
DISCUSSION
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