Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].
In Brazil, Remsima (CT-P13) was approved by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) in 2016 [3] based on a comparability exercise, thus becoming the first biosimilar drug for the treatment of psoriasis in the country. Then in 2017, the Health Department of Brazil’s Federal District demanded that the originator infliximab (Remicade) be substituted by a biosimilar (Remsima) in both treatment-naïve patients and those already in treatment.
In light of the Brazillian approval and substitution demands, authors from the country present their experience with the infliximab biosimilar in a 1-year follow-up study [4]. The study included 40 psoriasis patients who required or were already treated with infliximab, followed at the Brasilia University Hospital or at the Asa Norte Regional Hospital.
After the biosimilar was introduced, all participants were followed for one year. During this time, two patients reported mild worsening of their skin lesions, but no significant increase in the Psoriasis Area and Severity Index (PASI) score was observed. Two patients developed infliximab-related infusion reactions and one infliximab-naïve patient lost weight, had a strong reaction to the purified protein derivative (PPD) test, and developed pulmonary nodules after seven months of treatment with the biosimilar. The 35 remaining patients had no reactions or adverse effects and showed controlled skin and/or joint symptoms, with PASI scores ranging from 0 to 2.7.
The authors concluded that their results, ‘like previous European studies’ ‘suggest that the introduction or the switch to CT-P13 appears to be safe’. They added that ‘regarding drug efficacy, the original and the biosimilar showed similar results in most patients’. They did point out that ‘despite these positive results, most of our patients were clinically stable at the beginning of the study, showing good previous control’.
The authors also stated that ‘studies with larger cohorts and longer follow-up are still needed, but our preliminary results show that biosimilars may provide an opportunity to reduce health system costs because of their similarity to reference drugs in terms of safety and efficacy’.
Conflict of interest
The authors of the research paper [4] declared that there was no conflicts of interest.
Related articles
Switching from originator infliximab to CT-P13: real-world data with 24 months of follow up
Similar biotherapeutic products approved and marketed in Latin America
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
4. Kurizky PS, Galvão LO, Martins GA. Efficacy and safety of biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis: 1-year follow-up. An Bras Dermatol. 2019;94(4):483-4.
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment