Biosimilars in IBD: hope or expectation?

Introduction A biosimilar is a biological medicine that enters the market subsequent to expiration of the patent of an original reference product and its similarity to the reference medicine exhibits ‘no clinically meaningful differences in terms of quality, safety and efficacy’.1 In practice, patents protect a reference product for 10 years after its approval before registration for a similar biological medicine can be applied for.1 The term ‘biosimilar’ is recognised by all regulators, but synonyms include ‘similar biotherapeutic product’ (WHO) and ‘subsequent-entry biologic’ (Canada).2 Biopharmaceutical agents are derived from living cells or organisms and are usually complex proteins. Therefore, regulators are establishing novel specific approval pathways for biosimilars that differ from those for chemical generics. Since the first approval in 2005, several biosimilars of somatropin (human growth hormone), filgrastim (granulocyte colony-stimulating factor, G-CSF) and epoetin (erythropoietin) have become available in Europe. Currently, 12...

Source: Gut - April 30, 2013 Category: Gastroenterology Authors: Gecse, K. B., Khanna, R., van den Brink, G. R., Ponsioen, C. Y., Lowenberg, M., Jairath, V., Travis, S. P. L., Sandborn, W. J., Feagan, B. G., D'Haens, G. R. A. M. Tags: Crohn's disease Leading article Source Type: research