2014
DOI: 10.1111/ddg.12294
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Biosimilars in psoriasis: What can we expect?

Abstract: SummaryBiosimilars are biotechnologically processed drugs whose amino acid sequence is identical to the original biopharmaceutical. They are of considerable clinical, economical, and health care interest. As patents for biologicals used to treat psoriasis expire, biosimilars will become more and more important within the field of dermatology. The patents for the two top-selling drugs (adalimumab and etanercept) will terminate in the next few years. Applications for biosimilars will presumably be submitted to t… Show more

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Cited by 25 publications
(25 citation statements)
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“…Even small differences may have unforeseeable side effects, but it must be noted that even innovator companies cannot duplicate biologics from batch to batch, and thus far it seems like the variations do not have clinically significant consequences. (97)(98)(99) Before biosimilars can enter the market, they must show bioequivalence to the original biological agent, with far more evidence of similarity than we currently have for the batch-tobatch variations in the innovator products. Similar to branded biologics, registry of patients on biosimilars will allow for monitoring for AEs and comparison of efficacy between the biosimilar In April of 2016, Inflectra TM (infliximab-dyyb) was the first biosimilar to receive approval by the FDA for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.…”
Section: Expert Commentarymentioning
confidence: 99%
“…Even small differences may have unforeseeable side effects, but it must be noted that even innovator companies cannot duplicate biologics from batch to batch, and thus far it seems like the variations do not have clinically significant consequences. (97)(98)(99) Before biosimilars can enter the market, they must show bioequivalence to the original biological agent, with far more evidence of similarity than we currently have for the batch-tobatch variations in the innovator products. Similar to branded biologics, registry of patients on biosimilars will allow for monitoring for AEs and comparison of efficacy between the biosimilar In April of 2016, Inflectra TM (infliximab-dyyb) was the first biosimilar to receive approval by the FDA for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.…”
Section: Expert Commentarymentioning
confidence: 99%
“…Soweit aus ersten Observationsstudien erkennbar ist, gleichen die Nebenwirkungsspektren (Etanercept: TuNEX, HD203; Infl iximab: CT-P13, SB2, BOW015, SB4 und Adalimumab: ZRC-3197) denen der Originalprodukte, bei vergleichbarer Wirksamkeit und Verträglichkeit. Wiederum sind häufi ge kutane Nebenwirkungen Injektionsreaktionen und allergische Reaktionen in milder bis moderater Ausprägung [41][42][43] .…”
Section: Immunvermittelte Reaktionen Sowie Andere Komplikationenunclassified
“…The Biologics Price Competition and Innovation Act (BCPI) outlined a shortened approval process for "highly similar" biological products, which enables a biosimilar product to be evaluated against a single, already licensed, reference biologic therapy. In February 2012, the FDA issued a draft guidance for the industry regarding implementation of the BPCI Act approval process for BS agents [6], [7], [8], [9] and [10]. Data obtained from analytical and animal studies, and from at least one clinical trial conducted in patients with a disease for which the biological agent is licensed, will be required to demonstrate that a BS product is highly similar to the reference product [2] and [10].…”
Section: Regulatory Approvalmentioning
confidence: 99%