Biosimilar versus originator etanercept: a real-life clinical study

BACKGROUND: Over the last few years, novel therapeutic approaches based on the use of monoclonal antibodies against cytokines, or their cognate receptors, involved in psoriasis progression have shown remarkable results, being capable to reduce disease progression and increase patient's quality of life. Among these is etanercept (Enbrel (R), Pfizer, Sandwich, UK) and its biosimilar compound SB4 (Benepali (R), Samsung Bioepis, Delft, The Netherlands), both approved for the treatment of moderate to severe psoriasis. Aim of the present study was to evaluate in a less controlled environment, such as real-life, the actual bioequivalence between the etanercept (ETN) and the SB4 in term of safety, efficacy and patient's quality of life. METHODS: For this purpose, we analyzed a case study consisting of 65 patients affected by plaque psoriasis, with or without psoriatic arthritis at our dermatological outpatient center of Sant'Andrea Hospital in Rome, all of them under treatment with either ETN or the biosimilar SB4 drug for at least 3 months. The indicators used to evaluate the effectiveness of the therapies were the Psoriasis Area and Severity Index, the Visual Analogue Scale (VAS) for itch, the VAS for pain, and the Dermatology Life Quality Index. RESULTS. The results showed no significant differences among the two drugs in all the analyzed parameters confirming the equivalence be-tween the ETN and its biosimilar SB4. CONCLUSIONS: Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an un-controlled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.

Automated summary

The study aims to evaluate the bioequivalence between etanercept (ETN) and its biosimilar SB4 in a real-life setting. The results showed no significant differences between the two drugs in terms of efficacy, indicating that biosimilar drugs are a great opportunity to reduce healthcare costs and expand patient access to innovative treatments.