Currently, over 100 biosimilars are used in clinical practice and the total clinical experience with biosimilar medicines exceeds two billion treatment days. There are about forty biosimilar of nine originator mAbs authorized in the EU and US and there is no evidence of differences in safety, immunogenicity, and efficacy between biosimilar and originator products. One of the main reasons behind a dedicated regulatory pathway for similar biological medicinal products was the potential immunogenicity of biopharmaceuticals.
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