Biosimilars in dermatology: The wind of change (Review)

Abstract

Biosimilars are new drugs, highly similar copies of biological medicines, equally effective and safe but at lower prices. The aim of this brief review is to provide the current status of biosimilars approved in the European Union for dermatological use. We used PubMed for literature search up to June 2018. The keyword 'biosimilars' was searched and 1,691 items were found. From the 1,691 studies, we included 34 articles in our review. Biologics, biosimilars and generics are different types of drugs. Biosimilars are complex molecules produced by a difficult manufacturing process, and changes in product quality may affect its safety and efficacy. Now, there are 9 biosimilar medicines approved by European Medicines Agency (EMA) for plaque psoriasis and hidradenitis suppurativa: Amgevita, Solymbic, Cyltezo, Imraldi, Benepali, Erelzi, Flixabi, Inflectra and Remsima, and the number is increasing. In 2005, EMA issued the first guidelines for approval of biosimilars. Next-generation biologics, called 'biobetters', have the same target or mechanism of action as previously approved biologics, but they have structural changes and an improved formulation. The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world. Contents 1. Introduction 2. Literature search 3. Biologics, biosimilars and generics 4. Manufacturing biosimilars 5. Biosimilar medicines used in dermatology approved by EMA 6. The future pathway ahead 7. Conclusions

Prevalence and Characteristics of Psoriasis in Romania—First Study in Overall Population

“…Only one subject who considered himself healthy declared to be under treatment. Some psoriasis patients, even some dermatologists, are quite reluctant to undertake biologic therapy [18], even though it has demonstrated real efficacy in treatment of psoriasis and psoriatic arthritis [19], but novel biologics act by novel targets, technology, and mechanisms of action compared to previously approved biologics and the explosive development of biological therapy and the emergence of biosimilars, revolutionary tools against the most serious and provocative diseases which represent a significant success in the effort to provide advanced healthcare to patients all over the world [20][21][22]. To complete these results, an interesting study provides useful data on widely used biologic drugs and their tolerability, discontinuation rate, and the incurrence of severe adverse events [23].…”

Etiologic role of Borrelia�burgdorferi in morphea: A case report

“…In non-responsive patients, other systemic treatments may be beneficial: mycofenolate mofetil, colchicine or cyclosporine (15). Infliximab, an anti-TNF-α agent, is a human-murine chimeric drug, composed by a constant human region and a variable mouse region (16,17). Althought a report of a clinical case responding to this biologic agent exists, there are not enought data to support the efficacy of this drug (18).…”

Psoriatic arthritis: A permanent new challenge for dermatologists (Review)

“…Regarding biologic therapies, in recent years, there has been an increasing interest in developing new biologic treatments for psoriasis and psoriatic arthritis, therefore, there are many therapies available in Romania, among which: anti-TNF-α inhibitors, anti-IL-12/23 inhibitors and anti-IL-17 inhibitors. Among anti-TNF-α inhibitors, the general safety profile of etanercept when it comes to the risk of infection and hepatotoxicity in patients with psoriasis, psoriatic arthritis and rheumatoid arthritis is higher than that of the other anti-TNF-α agents and, unlike the other anti-TNF agents, neutralizes the biological activity of both TNF-α and lymphotoxin-α (19,20).…”

“…This reassurance comes from the evidence that has been generated before marketing authorization, and in particular from RCTs as an important part of it. Unfortunately, at present there is rather limited evidence provided by the clinical trials, especially on psoriasis and psoriatic arthritis, which would help a dermatologist feel more comfortable about prescribing biosimilars (20).…”