GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods

Richter, Oliver von; Lemke, Lena; Haliduola, Halimu N.; Fuhr, Rainard; Koernicke, Thomas; Schuck, Ellen; Velinova, Maria; Skerjanec, Andrej; Poetzl, Johann; Jauch-Lembach, Julia

doi:10.1080/14712598.2019.1571580

Cited by 29 publications

(33 citation statements)

References 20 publications

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“…GP2017 was approved by the FDA and EMA in 2018. Previous studies demonstrated that GP2017 and Humira have identical amino acid sequences, indistinguishable secondary and tertiary structures, the same level of post-translational modifications, and a functional and pharmacological similarity to the reference drug (20,21). Wiland et al (22,23) conducted a phase III trial including 353 moderate-to-severe RA patients with inadequate response to disease modifying anti-rheumatic drugs.…”

Section: Gp2017 (Hyrimoz/hefya/halimatoz)mentioning

confidence: 99%

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lin

et al. 2021

Front. Immunol.

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Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented. In this review, we summarized clinical trials of seven biosimilars currently approved by the FDA and/or EMA for the treatment of rheumatoid arthritis, namely: ABP 501 (Amjevita/Amgevita/Solymbic), BI 695501 (Cyltezo), SB5 (Imraldi/Hadlima), GP2017 (Hyrimoz/Hefiya/Halimatoz), MSB11022 (Idacio), FKB327 (Hulio), and PF-06410293 (Abrilada). Overall, these biosimilars showed similar efficacy, safety, and immunogenicity to adalimumab. All biosimilar switching trials indicated that switching from adalimumab to a biosimilar does not have a significant impact on efficacy, safety, and immunogenicity.

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Section: Gp2017 (Hyrimoz/hefya/halimatoz)mentioning

confidence: 99%

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lin

et al. 2021

Front. Immunol.

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“…Results from sensitive in vitro binding, functional characterization studies, and nonclinical evaluations have established that GP2017 is similar to the adalimumab RP regarding target binding, functional PK, and PD properties [21]. The PK of GP2017 were compared with EU-Humira and US-Humira in a randomized, double-blind, parallelgroup study among 316 healthy male subjects [22]. Ten subjects were ADA positive at baseline and were excluded from the PK analysis and two subjects discontinued the study, leaving 306 subjects in the PK analysis set (GP2017, n = 104; EU-Humira, n = 103; US-Humira, n = 99).…”

Section: Gp2017mentioning

confidence: 99%

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

2020

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Although treatment with biologic diseasemodifying antirheumatic drugs (bDMARDs) has significantly improved clinical outcomes in patients with rheumatoid arthritis (RA), many patients do not have access to these treatments. As cost-effective alternatives to their reference products (RPs), biosimilars provide an opportunity to increase access to bDMARDs. The European Medicines Agency and the US Food and Drug Administration have detailed pathways for the approval of biosimilars based on establishing the similarity of the biosimilar to the RP in terms of structure and function, pharmacokinetics (PK), efficacy, safety, and immunogenicity. A number of biosimilars of adalimumab, infliximab, etanercept, and rituximab RPs have been approved in the United States and/or European Union. This article is focused on the seven adalimumab biosimilars. A review of the data for the biosimilars FKB327, ABP 501, BI 695501, GP2017, MSB11022, PF-06410293, and SB5 confirm that these products are highly similar to the adalimumab RP with regard to structure, physicochemical and biological properties, PK, safety, immunogenicity, and efficacy in the treatment of RA and other chronic immune-mediated, inflammatory conditions. Data from several switching studies showed no changes in efficacy, safety, trough serum drug concentration, or immunogenicity between the biosimilars and their RP. Trial registration: ClinicalTrials.gov identifiers: NCT02260791,

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“…16 As in previous studies comparing administration of adalimumab biosimilars by both AI and PFS, headache and ISRs were among the most common TEAEs in this study. 27,28,30 Compared with subjects in the CT-P17 PFS group, a greater number of subjects in this study who received CT-P17 by AI reported musculoskeletal pain, ISRs and transient blood CPK increases; such…”

Section: Comparability Of Pk Parameters Between Ct-p17 Ai and Ct-p17mentioning

confidence: 74%

Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects

Davidson

Brimhall

Kay

et al. 2021

Brit J Clinical Pharma

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area under the concentration-time curve from time zero to infinity (AUC 0-inf ); area under the concentration-time curve from time zero to the last quantifiable concentration (AUC 0-last ); maximum serum concentration (C max ). Equivalence was determined if the 90% confidence interval for the geometric least-squares mean ratio was within the 80-125% equivalence margin. Additional pharmacokinetic endpoints, safety and immunogenicity were evaluated.Results: Of 193 subjects who were randomised (98 CT-P17 AI; 95 CT-P17 PFS), 180 received study drug. Pharmacokinetic equivalence was demonstrated: 90% confidence intervals were within the 80-125% equivalence margin (AUC 0-inf : 93.98-114.29; AUC 0-last : 91.09-121.86; C max : 94.08-111.90). Mean serum CT-P17 concentrations, secondary pharmacokinetic parameters and numbers of subjects with antidrug antibodies (ADAs) or neutralising ADAs were comparable between groups. AUC 0-inf , AUC 0-last and C max were numerically lower for ADA-positive than for ADAnegative subjects (both groups); pharmacokinetic equivalence was also demonstrated among ADA-positive subjects. CT-P17 AI and CT-P17 PFS were well tolerated, with comparable overall safety profiles.Conclusions: CT-P17 AI and CT-P17 PFS were pharmacokinetically equivalent.Overall safety and immunogenicity were comparable between the 2 delivery devices.

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GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods

Cited by 29 publications

References 20 publications

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects

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