Biosimilars: a new generation of biologics

Due to their origins and complexity, biotechnological medicinal products are,compared to chemical products, difficult to reproduce. Now, biotechnological medicinal products, introduced to the market since 1990 are no longer covered by their protection certificates, making it possible to apply for a marketing authorisation for the same active substance as the reference product.In response to this new situation, the European Commission issued a regulation on so-called 'medicinal products biologically similar to reference products'?, creating the regulatory concept of 'biosimilar medicinal products.'?.Though the substitution, by the pharmacist, of generic chemical medicinal products is subject to applicable legislation, this is not the case for biosimilars. The decision on the interchangeability of the reference product and its biosimilar is a medical act under the prescriber's responsability. The present work addresses thelegal regulatory framework, analyses the contexts of biotechnological medicinal products along with the conditions for their registration, and helps to shed light on the post-market authorization problematic, while also discussing the associated financial costs.It is primarily intended for prescribing doctors and for pharmacists working in hospitals, but also for the broad range of actors in the health sector who want to better understand the emergence of these new medicinal products from the perspective of their prescription and proper utilisation.

• ISBN: 978-2-8178-0335-7
• Editorial: Springer
• Encuadernacion: Cartoné
• Fecha Publicación: 30/09/2012
• Nº Volúmenes: 1
• Idioma: Inglés