Abstract
Biosimilars, as highly similar alternatives to originator biologic drugs, are poised to transform the pharmaceutical landscape by offering cost-effective therapeutic options. However, their development is complex, involving stringent regulatory pathways, analytical characterization, and clinical validation. This article explores the multifaceted challenges in biosimilar development, such as structural heterogeneity, immunogenicity concerns, and manufacturing scalability. It also highlights the evolving global regulatory frameworks and future trends that promise a more streamlined approach to biosimilar approval. With advancements in analytical technologies and bioprocessing, biosimilars have the potential to enhance patient access to life-saving biologics without compromising quality or efficacy.
All articles published in the American Journal of Pharmaceutics are open access and licensed under the Creative Commons Attribution 4.0 International License (CC BY 4.0). This license allows users to:
-
Share — copy and redistribute the material in any medium or format
-
Adapt — remix, transform, and build upon the material for any purpose, even commercially
Under the following terms:
-
Attribution — Appropriate credit must be given, a link to the license must be provided, and any changes must be indicated.
-
Authors retain full copyright of their work.
-
The journal does not restrict reuse of content, provided proper citation of the original publication is made.