Insight into Biosimilars: Short Description, Analytical Assessment and Market

Abstract

The World Health Organization (WHO) defines a similar biotherapeutic product, i.e. a biosimilar as a biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference product on the market (termed as originator or innovator). To ensure similar efficacy and safety, comparability studies for biosimilars should be carried out at quality, preclinical and clinical level. Glycosylation profiles of biosimilars are getting an additional critical quality attribute. The portfolio required for regulatory comparison of identity and release testing has to be assessed with a large number of analytical tests, which are presented here in detail for the example of adalimumab. Adalimumab, as one of the blockbuster drugs and the best-selling pharmaceutical product world-wide, is analyzed additionally with a competitive field presenting the marketed products or such in development. This competitive field is not surprisingly very crowded. Furthermore, general information about the currently marketed biosimilars including Mode of Action (MoA), clinical indication(s), patent situation, and market situation are shortly summarized for each of the respective originator / biosimilar molecules. As there are not only markets in developed and highly regulated countries, but also in other regions, examples for companies and products in Asia, South and Middle America, and even in Africa are highlighted as well.