Regulation of Biosimilars: A Matter of Variability, Similarity and Comparability.

The article discusses the move of the European Union to strengthen its role in regulating biosimilars by developing basic regulations for determining their compatibility and safety. It notes the workshop on biosimilars organized by the European Medicines Agency (EMA), which focused on the revised guideline, principles, and quality issues of biosimilars. However, it also mentions the lack of knowledge on some aspects of biosimilars which needs more learning on how they should be regulated.