Literature DB >> 27639072

Biosimilars for psoriasis: clinical studies to determine similarity.

A Blauvelt1, L Puig2, S Chimenti3, R Vender4,5, M Rajagopalan6, R Romiti7, L Skov8, C Zachariae8, H Young9, E Prens10, A Cohen11,12, J van der Walt13, J J Wu14.   

Abstract

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.
© 2016 British Association of Dermatologists.

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Year:  2017        PMID： 27639072     DOI： 10.1111/bjd.15067

Source DB:  PubMed          Journal:  Br J Dermatol        ISSN： 0007-0963            Impact factor:   9.302


  6 in total

Review 1.  How similar are the treatment responses to biosimilars in patients with psoriasis? A systematic review of statistical margins in comparative clinical trials.

Authors:  Marilyn T Wan; Bruce E Strober; Jashin J Wu; Daniel B Shin; Joel M Gelfand
Journal:  J Am Acad Dermatol       Date:  2017-09       Impact factor: 11.527

2.  Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis Council.

Authors:  Arnon D Cohen; Ronald Vender; Luigi Naldi; Robert E Kalb; Tiago Torres; Murlidhar Rajagopalan; Joelle van der Walt; Lluís Puig; Helen S Young
Journal:  JAAD Int       Date:  2020-11-23

3.  Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes.

Authors:  Hillel P Cohen; Andrew Blauvelt; Robert M Rifkin; Silvio Danese; Sameer B Gokhale; Gillian Woollett
Journal:  Drugs       Date:  2018-03       Impact factor: 9.546

4.  AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.

Authors:  J Hercogová; K A Papp; V Chyrok; M Ullmann; P Vlachos; C J Edwards
Journal:  Br J Dermatol       Date:  2019-09-26       Impact factor: 9.302

Review 5.  Old and New Biological Therapies for Psoriasis.

Authors:  Kirsten Rønholt; Lars Iversen
Journal:  Int J Mol Sci       Date:  2017-11-01       Impact factor: 5.923

Review 6.  The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence.

Authors:  Brian G Feagan; Mona Marabani; Jashin J Wu; Freddy Faccin; Claire Spronk; Gilberto Castañeda-Hernández
Journal:  Adv Ther       Date:  2020-09-10       Impact factor: 3.845
  6 in total

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