Biosimilars for psoriasis: clinical studies to determine similarity

被引:12
作者
Blauvelt, A. [1 ]
Puig, L. [2 ]
Chimenti, S. [3 ]
Vender, R. [4 ,5 ]
Rajagopalan, M. [6 ]
Romiti, R. [7 ]
Skov, L. [8 ]
Zachariae, C. [8 ]
Young, H. [9 ]
Prens, E. [10 ]
Cohen, A. [11 ,12 ]
van der Walt, J. [13 ]
Wu, J. J. [14 ]
机构
[1] Oregon Med Res Ctr, Portland, OR 97223 USA
[2] Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Dept Dermatol, Barcelona, Spain
[3] Univ Rome Tor Vergate, Rome, Italy
[4] Dermatrials Res Inc, Hamilton, ON, Canada
[5] Venderm Innovat Psoriasis, Hamilton, ON, Canada
[6] Apollo Hosp, Chennai, Tamil Nadu, India
[7] Univ Sao Paulo, Dept Dermatol, Sao Paulo, Brazil
[8] Univ Copenhagen, Herllev & Gentofte Hosp, Copenhagen, Denmark
[9] Univ Manchester, Manchester Acad Hlth Sci Ctr, Salford Royal Hosp, Dept Dermatol, Manchester, Lancs, England
[10] Erasmus Univ, Med Ctr, Dept Dermatol, Rotterdam, Netherlands
[11] Ben Gurion Univ Negev, Fac Hlth Sci, Siaal Res Ctr Family Med & Primary Care, Beer Sheva, Israel
[12] Clalit Hlth Serv, Chief Phys Off, Dept Qual Measurements & Res, Tel Aviv, Israel
[13] Int Psoriasis Council, St Louis, MO USA
[14] Kaiser Permanente Los Angeles Med Ctr, Dept Dermatol, Los Angeles, CA USA
关键词
DOUBLE-BLIND; PHASE-III; INFLIXIMAB; THERAPY; INTERCHANGEABILITY; EXTRAPOLATION; RHEUMATOLOGY; ADALIMUMAB; MODERATE; SAFETY;
D O I
10.1111/bjd.15067
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.
引用
收藏
页码:23 / 33
页数:11
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