#approfondimenti

Per approfondire ulteriormente questi temi, ecco una selezione di documenti e di link.

DOCUMENTI

Farmaci biotecnologici e biosimilari – La rivoluzione dei biotech: dalle eritropoietine agli anticorpi monoclonali in oncologia, AIOM 2013. [PDF 1432 kb]

Position Paper sui Farmaci Biosimilari, AIFA 2013 [PDF 213 kb]

“I Rapporto nazionale sui Farmaci Biologici e Biosimilari” – Sintesi, Cittadinanzattiva 2013. [PDF 4907 kb]

Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I on behalf of SIR, SIDeMaST, and IG-IBD. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmunity Reviews 2014;13:751–755. [PDF 245 kb]

LINK

Position Paper del Consiglio Direttivo della SIF – Biosimilari: Opportunità e Problematiche, Estratto da Quaderni della SIF (2007) vol. 10.

Revisione della posizione sui farmaci biosimilari da parte della Società Italiana di Farmacologia: working paper 2014.

European Medicines Agency’s scientific guidelines on biosimilar medicines.

FDA Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.

Position Paper AIFA sui Farmaci Biosimilari 2013.

Da un’indagine pan-europea un quadro sull’impiego dei biosimilari nella pratica clinica, AIFA 2014.

LETTERATURA SCIENTIFICA

Dörner T, Strand V, Castañeda-Hernández G, Ferraccioli G, Isaacs JD, Kvien TK, Martin-Mola E, Mittendorf T, Smolen JS, Burmester GR. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-328 doi:10.1136/annrheumdis-2012-202715

Gecse KB, Khanna R, van den Brink GR, Ponsioen CY, Löwenberg M, Jairath V, Travis SPL, Sandborn WJ, Feagan BG, D’Haens GRAM. Biosimilars in IBD: hope or expectation? Gut 2013;62:803-807 doi:10.1136/gutjnl-2012-303824

Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Setting the stage for biosimilar monoclonal antibodies. Nature Biotechnology 2012;30:1179–1185 doi:10.1038/nbt.2447

Danese S, Gomollon F on behalf of the Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD).J Crohns Colitis 2013;7(7):586-9 doi: 10.1016/j.crohns.2013.03.011

Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T (Multidisciplinary Working Group on Biosimilars and Inflammatory Bowel Disease of the Spanish Society of Gastroenterology and Spanish Society of Pharmacology). Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2013;105(1):37-43.

Fonseca JE, Gonçalves J, Araújo F, Cordeiro I, Teixeira F, Canhão H, da Silva JA, Garcês S, Miranda LC, Ramiro S, Roxo A, Pimentel-Santos FM, Tavares V, Neto A, Sepriano A, Malcata A, Faustino A, Silva C, Ambrósio C, Duarte C, Miguel C, Barcelos F, Santos H, Cunha I, Ramos JC, Gomes JA, Pimentão JB, Costa L, Maurício L, Silva M, Bernardes M, Bogas M, Coelho PC, Monteiro P, Aguiar R, André R, Leitão R, Pimenta S, Meirinhos T, Fernandes S, Las V, Castelão W; Sociedade Portuguesa de Reumatologia. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol Port 2014;39(1):60-71. [PDF 200 kb]

Schreiber S, Luger T, Mittendorf T, Mrowietz U, Müller-Ladner U, Schröder J, Stallmach A, Bokemeyer B. Evolution der Biologika in der Entzündungsmedizin – Biosimilars in Gastroenterologie, Rheumatologie und Dermatologie. Dtsch med Wochenschr 2014;139(47):2399-2404 doi:10.1055/s-0034-1387371