Biosimilars: a new challenge in the current pharmacology

In a review of biosimilars in rheumatology author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain discuss issues surrounding biosimilars*.

The biological market is constantly growing. These drugs have experienced huge advances in dealing with many different diseases such as rheumatoid arthritis (RA), diabetes or cancer and it is hoped that they will continue doing so. Such benefits, however, also come with increased treatment costs, therefore, challenging the access and sustainability of health systems. When biologicals licenses have expired, biosimilars may be approved, lowering prices and increasing access to these drugs.

Nowadays, the biosimilars market is small, representing 3% in 2010 with respect to the sales of the reference biological (somatotropin, epoetin and filgrastim) and only 0.7% of the total pharmaceutical market. However, following patent expiry of drugs such as infliximab, adalimumab, etanercept, rituximab, cetuximab, trastuzumab and bevacizumab, the biosimilar market is expected to grow [1]. In Europe, it is expected that biosimilars will cut prices by 20‒30% in comparison with the reference biologicals, which will also reduce its price in order to remain competitive. This has already happened with filgrastim or epoetin, whose prices have dropped by 40% in the last few years.

In view of these circumstances, it is a priority that all players involved in the use of biological drugs to familarize with these drugs.

A more detailed discussion of the issues surrounding biosimilars is presented in a series of four articles.

This article is prepared based on the paper entitled ‘Biosimilars: a new challenge in the current pharmacology’ by Serra-Matencio JM, Ramirez-Herraiz E, Morell-Baladron A, Castañeda S.Hospital de La Princesa, IIS-IP, Madrid, Universidad Autónoma, Madrid, Spain.

Editor’s comment
Readers interested to learn more about biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Product naming, pricing, and market uptake of biosimilars

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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Biosimilars: management of clinical issues

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Biologicals: characteristics that make them unique and special

1. GaBI Online – Generics and Biosimilars Initiative. Biologicals patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from:


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