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Introduction: SB17 is a biosimilar to reference ustekinumab (UST). We compared the efficacy, safety, and immunogenicity of SB17 to UST up to Week 52, including switching from UST to SB17., Methods: Subjects were randomized to receive 45 mg of SB17 or UST subcutaneously up to Week 40. At Week 28, subjects from the UST treatment group were re-randomized to either switch to SB17 or continue UST. Efficacy, safety, and immunogenicity were assessed up to Week 52., Results: Among baseline randomized 503 subjects, 481 subjects were re-randomized at Week 28; continuing SB17 (SB17 + SB17, n  = 237), switching from UST to SB17 (UST+SB17, n  = 122) or continuing UST (UST+UST, n  = 122). The percent change from baseline in Psoriasis Area and Severity Index (PASI) was comparable between treatment groups up to Week 52 (SB17 + SB17: 95.8%, UST+SB17: 95.6%, UST+UST: 94.5% at Week 52). Other efficacy endpoints were also comparable. The incidence of treatment-emergent adverse events (SB17 + SB17: 16.5%, UST+SB17: 13.9%, UST+UST: 23.8%) and the overall incidence of anti-drug antibodies occurring after transition were comparable between treatment groups (SB17 + SB17: 5.6%, UST+SB17: 5.1%, and UST+UST: 6.7%)., Conclusion: SB17 demonstrated clinical biosimilarity to UST after switching from UST, and maintained long-term comparable efficacy and safety with UST up to Week 52.

Background: Ustekinumab (UST) is a safe and effective treatment for moderate-to-severe psoriasis., Objectives: To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed UST biosimilar SB17 with reference UST in subjects with moderate-to-severe plaque psoriasis., Methods: In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at week 0, 4, and every 12 weeks. The primary endpoint was the percent change from baseline in Psoriasis Area and Severity Index at week 12 with an equivalence margin of [-15%, 15%]. Other secondary efficacy, safety, PK, and immunogenicity endpoints were measured through week 28., Results: Two hundred forty-nine subjects were randomized to SB17, 254 to UST. Adjusted difference of Psoriasis Area and Severity Index change from baseline at week 12 of -0.6% (95% confidence interval; -3.780, 2.579) was within the equivalence margin. Physician's Global Assessment and Dermatology Life Quality Index were also comparable. Overall treatment-emergent adverse events were comparable (SB17: 48.2%, UST: 48.8%). The overall incidence of antidrug antibodies up to Week 28 was 13.3% with SB17 and 39.4% with UST., Limitations: Data were only through week 28., Conclusion: SB17 was clinically biosimilar to UST up to week 28., Competing Interests: Conflicts of interest Dr Feldman has received research, speaking, and/or consulting support from Eli Lilly and Company, GlaxoSmithKline/Stiefel, AbbVie, Janssen, Alovtech, vTv Therapeutics, Bristol-Myers Squibb, Samsung Bioepis, Pfizer, Boehringer Ingelheim, Amgen, Dermavant, Arcutis, Novartis, Novan, UCB, Helsinn, Sun Pharma, Almirall, Galderma, Leo Pharma, Mylan, Celgene, Ortho Dermatology, Menlo, Merck & Co, Qurient, Forte, Arena, Biocon, Accordant, Argenx, Sanofi, Regeneron, the National Biological Corporation, Caremark, Teladoc, BMS, Ono, Micreos, Eurofins, Informa, UpToDate, and the National Psoriasis Foundation. Dr Feldman is founder and part owner of Causa Research and holds stock in Sensal Health. Dr Narbutt is an investigator and/or lecturer for Novartis, Eli Lilly, Almirall, AbbVie, Celltrion, Pfizer, Leo Pharma, Janssen, and UCB and participated in SB17-3001 study as an investigator and received investigational grant from Samsung Bioepis. Dr Girolomoni has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Leo Pharma, Merck Serono, Novartis, Pfizer, Samsung Bioepis, and Sanofi. Drs Brzezicki, Reznichenko, Zegadlo-Myłik, Pulka, Dmowska-Stecewicz, Klujszo, Rekalov, and Rajzer participated in SB17-3001 study as an investigator and received investigator grants from Samsung Bioepis. Authors J. Lee, M. Lee, and Dr Rho are employees of Samsung Bioepis Co, Ltd and owns stocks of Samsung Biologics., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: AVT02 (adalimumab) is a proposed biosimilar to Humira ® . AVT02 is produced at a 100 mg/mL concentration with a citrate-free formulation., Objectives: The aim of this study was to compare the efficacy, safety and immunogenicity of AVT02 versus Humira ® in subjects with moderate to severe chronic plaque psoriasis., Methods: This double-blind, randomised, parallel group, active control study of adult subjects compared (at a 1:1 ratio) AVT02 with originator adalimumab 80 mg subcutaneously in Week 1, then 40 mg every other week. At Week 16, subjects who had received originator adalimumab were re-randomised at a 1:1 ratio to continue receiving originator adalimumab, or to switch to AVT02, every other week until Week 48, with final efficacy endpoint at Week 50. Subjects who initially received AVT02 continued to receive AVT02 from Week 16 to Week 48. The primary endpoint was percentage improvement in Psoriasis Area and Severity Index (PASI) score at Week 16. Secondary efficacy endpoints included percentage improvement in PASI score at additional timepoints, change from baseline in Dermatology Life Quality Index (DLQI) score and number and percentage of subjects achieving static Physician's Global Assessment (sPGA) responses of 'clear' or 'almost clear'. Additional secondary endpoints included comparison of adverse event profiles, anti-drug antibodies and neutralising antibodies, and serum trough levels of adalimumab at steady state., Results: A total of 413 subjects were randomised (205 to AVT02 and 208 to originator). The percentage improvement in PASI score at Week 16 was 91.6% for AVT02-treated subjects and 89.6% for originator adalimumab. The 90% confidence intervals for the primary endpoint were within the pre-defined equivalence margin of ±10% (90% CI - 0.76 to 5.29; 95% CI - 1.34 to 5.88), and a comparable pattern for DLQI score (11.4-point and 10.6-point improvement in AVT02-treated and originator adalimumab-treated groups, respectively) and sPGA (90.5% in both groups achieving 'clear' or 'almost clear') at Week 16 supported the assessment. Efficacy persisted through Week 50 of the study in all treatment groups, including those who switched from originator adalimumab to AVT02, for percent improvement in PASI score, quality-of-life assessment and sPGA. The safety, tolerability and immunogenicity profiles between AVT02 and originator adalimumab were similar at Week 16, and this persisted in the switched and continued groups through Week 50., Conclusion: Objective and subjective measures of efficacy supported the evaluation of biosimilarity between AVT02 and originator adalimumab at Week 16 and until Week 50, in switched and continued treatment groups. AVT02 was safe and well tolerated, with a safety and immunogenicity profile similar to that observed in originator adalimumab with no clinically meaningful difference between the two., Clinical Trial Registration: EudraCT: 2017-003367-35; ClinicalTrials.gov: NCT03849404., (© 2021. The Author(s).)

Background: GP2015 is a proposed etanercept biosimilar., Objectives: To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and the etanercept originator (ETN, Enbrel ® ) in patients with moderate-to-severe chronic plaque-type psoriasis., Methods: In total, 531 eligible patients were randomized 1 : 1 to self-administer GP2015 or ETN twice weekly subcutaneously. Patients with ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were rerandomized to continue the same treatment on a once-weekly dosing schedule or to undergo a sequence of three treatment switches between GP2015 and ETN until week 30. Thereafter, patients continued treatment with the product they had been assigned to last, up to week 52., Results: The difference in PASI 75 (75% improvement from baseline PASI score) response rates at week 12 between GP2015 and ETN (primary end point) was -2·3%. The 95% confidence interval (-9·85 to 5·30) was well contained within the prespecified margin range of -18 to 18. The incidence of treatment-emergent adverse events up to week 52 was comparable between continued GP2015 (59·8%) and ETN (57·3%); switching treatments revealed comparable safety profiles. Antidrug antibodies, all non-neutralizing, were limited to five patients on ETN during treatment period 1, and one patient in the switched ETN group, who had been treated with GP2015 for 12 weeks at the time of the finding., Conclusions: The EGALITY study demonstrated equivalent efficacy and comparable safety and immunogenicity of GP2015 and ETN. The study results provide the final clinical confirmation of biosimilarity and contribute to the totality of the evidence proposing that GP2015 is an etanercept biosimilar., (© 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)