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Recenti Prog Med. 2017 Jan;108(1):11-13. doi: 10.1701/2624.26979.

[Equivalence, equity and evidence for the use of biosimilar drugs.]

[Article in Italian]

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Dipartimento di Epidemiologia del Servizio sanitario della Regione Lazio.


At present, biosimilar drugs are one of the potential tools capable to allow the access to biological pharmacotherapy in a context of limited resources. Even though universal standards have been determined, prescribers are often unaware of the meaning of the evaluation which assures correct equivalence of biosimilar with the originator product. On the other hand, comparative efficacy and safety studies between biosimilars and originators are often lacking. These might be some of the limiting factors for a wider use of such therapeutic tools by the health practitioners. As a consequence, skepticism and potential legal issues are dominating the scientific discussion on this topic hindering the discussion on clinical issues related to the use of biosimilars (e.g, switching's safety; head to head effectiveness data versus originators, etc.). To overcome existing barriers, the Committee for Medicines of the Lazio Region established a specific pathway in order to share with researchers and practitioners the available evidence as well as to investigate the hypothesis of efficacy and safety differences using real world data. This might represent a novel approach to transfer the right information in the clinical practice. However, to improve the correct use of biosimilar drugs we need to develop new strategies taking into account national and international best practices capable to involve all stakeholders.

[Indexed for MEDLINE]

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