| アブストラクト | The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies. |
|---|
| 投稿者 | Cohen, A D; Wu, J J; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; de la Cruz, C; Skov, L; Zachariae, C; Young, H S; Foley, P; van der Walt, J M; Naldi, L; Prens, E P; Blauvelt, A |
|---|
| 組織名 | Siaal Research Center for Family Medicine and Primary Care, Faculty of Health;Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.;Department of Quality Measurements and Research, Chief Physician's Office, Clalit;Health Services, Tel Aviv, Israel.;Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los;Angeles, CA, U.S.A.;Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat;Autonoma de Barcelona, Barcelona, Spain.;University of Rome Tor Vergata, Rome, Italy.;Dermatrials Research Inc. & Venderm Innovations in Psoriasis, Hamilton, ON,;Canada.;Department of Dermatology, Apollo Hospitals, Chennai, India.;Department of Dermatology, University of Sao Paulo, Sao Paulo, Brazil.;Clinica Dermacross, Santiago, Chile.;Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University;of Copenhagen, Copenhagen, Denmark.;The University of Manchester, Manchester Academic Health Science Centre,;Manchester, U.K.;Department of Dermatology, Salford Royal NHS Foundation Trust, Manchester, U.K.;Skin & Cancer Foundation Inc., Carlton, Vic., Australia.;Department of Dermatology, The University of Melbourne, Melbourne, Vic.,;Australia.;St Vincent's Hospital, Melbourne, Vic., Australia.;International Psoriasis Council, St Louis, MO, U.S.A.;Department of Dermatology, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo,;Italy.;Deptartment of Dermatology, Erasmus MC, P.O. Box 5201, 3008, AE Rotterdam, the;Netherlands.;Oregon Medical Research Center, Portland, OR, U.S.A. |
|---|
