Biosimilars versus original biologics. Similarities and differences from development to approval

Zeitschrift für Rheumatologie
J Windisch

Abstract

Due to the expiry of patents for biological pharmaceuticals, in forthcoming years there will be an increase in the approval of biosimilars by the international health authorities. This will bring potential savings in the range of 11.8-33.4 billion euros in the European Union (EU) in the year 2020. The aims are an understanding of the natural variability of biological substances and the clinical relevance of the diverse product attributes, proof of comparability (similarity) as a self-contained concept in the development and approval of biosimilars and importance of extrapolation to other indications when comparability is demonstrated by comprehensive analytical and functional studies. This study involved an assessment of the regulations of the European licensing authority, the European Medicines Agency (EMA), with respect to the approval of biosimilars, analytical, physicochemical and biological procedures for determination of comparability and the permissible deviation from the reference product Approved biological pharmaceuticals have a natural intrinsic variability, e.g. with respect to glycosylation. Furthermore, different batches in the manufacturing process can be different or the manufacturing process itself can be subje...Continue Reading

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Citations

Jul 2, 2016·Zeitschrift für Rheumatologie·J R Kalden
Jun 24, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·K BlackwellN Harbeck

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