Noninferiority of biosimilar MSB110222 to reference adalimumab for chronic plaque psoriasis
- PMID: 31840231
- DOI: 10.1111/bjd.18717
Noninferiority of biosimilar MSB110222 to reference adalimumab for chronic plaque psoriasis
Comment on
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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.Br J Dermatol. 2020 Feb;182(2):316-326. doi: 10.1111/bjd.18220. Epub 2019 Sep 26. Br J Dermatol. 2020. PMID: 31206593 Free PMC article. Clinical Trial.
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References
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- Sarpatwari A, Barenie R, Curfman G et al. The US biosimilar market: stunted growth and possible reforms. Clin Pharmacol Ther 2019; 105:92-100.
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- Blauvelt A, Cohen AD, Puig L et al. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol 2016; 174:282-6.
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- U.S. Department of Health and Human Services, Food and Drug Administration. Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. May 2019. Available at: https://www.fda.gov/media/125484/download (last accessed 13 November 2019).
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- Hercogová J, Papp KA, Chyrok V et al. 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. Br J Dermatol 2020; 182:316-26.
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- Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol 2015; 29:645-8.
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