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 the EMA and the FDA for all patent-free biologicals. Both regulatory bodies have issued guidelines on the assessment of bioequivalence, as well as the benefits and risks of biosimilars. While the preclinical requirements of the FDA and EMA are largely comparable, the formal requirements for clinical bioequivalence, including clinical efficacy and safety, differ markedly. Therefore, from a medical and health care perspective before biosimilars enter the market, specific evidence-based regulatory conditions need to be created and fulfilled. Only then biosimilars can be a less expensive option for a large number of patients, providing them with substances of the same value. Adequate, unequivocal proof of their bioequivalence, quality, and related patient safety should have priority over any ostensible economic benefits.

Current status and future prospects for biologic treatments of psoriasis

“…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.…”

Cutaneous side effects of TNF‐alpha inhibitors

“…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] .…”

Biosimilar vs biological agents in rheumatology: When are biosimilar agents similar enough?

“…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].…”