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

BACKGROUND: 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.

OBJECTIVES: 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.

MATERIAL AND METHODS: 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

RESULTS: 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 subject to change. Biosimilars are subject to specific and strict approval criteria with the aim of restricting the product attributes to lie within the variability range of the original biologics, can only show deviations from the original preparations within very narrow limits and must show proven safety, quality and effectiveness comparable to them.

DISCUSSION: The development and approval concept of biosimilars has been proven for nearly 10 years. Strict requirements by the EMA guarantee the highest quality standards, which have led to significant savings in the healthcare system and an expansion of access to biological pharmaceuticals in many countries and for many patients.