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Biosimilars
A New Generation of Biologics
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Due to their origins and to the complexity of their molecular structure and efficacy profiles, biological and biotechnological medicinal products are, compared to chemical products, difficult to reproduce. Now, however, chemical medicinal products, biological medicinal products, and above all recombinant proteins 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." This concept is based on an "abridged" development of biosimilars, which is aimed at determining with the help of comparability studies, the degree of similarity between them and their reference products in terms of quality, safety and efficacy.Recently, the FDA has also started considering these aspects (Biologics Price Competition and Innovation Act of 2009; Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Notice of Public Meeting; Request for Comments). Though the substitution of generic chemical medicinal products is subject to applicable legislation, this is not the case for biosimilars, which are not included on the lists of generic substitutes because they do not fulfil the conditions listed in the definition of generic medicinal products. The decision on the interchangeability of the reference product and its biosimilar depends on a protocol that takes into account the patient, the typology of the medical condition, the characteristics of the medicinal product, and its specific form of distribution in the body. In fact, the complexity of production and the investment costs involved in bringing biosimilars to market is different from those for generics.The present work addresses the legal regulatory framework, analyses the contexts of biotechnological and biological 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.
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ISBNs
2817803361
9782817803357
9782817803364