A Systematic Literature Review of Injection Site Pain Perception in Adult
Patients Treated with Citrate-Free and Citrate-Containing Biologic Agents

Junker, Sophia; Ebert, Oliver; Bartsch, R.

doi:10.2174/1573397118666220829123713

Cited by 5 publications

(2 citation statements)

References 37 publications

(49 reference statements)

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“…As seen with REF-ADL and HCF REF-ADL, HCF SDZ-ADL increases the drug concentration from 50 mg/ml in the initially approved formulation to 100 mg/ml, thus decreasing injection volume and potentially the number of injections, which can improve patient convenience [ 27 ]. Additionally, there is concern among healthcare professionals regarding the use of citrate buffer due to the apparent potential to induce injection site pain at concentrations > 50 mM in adalimumab formulations; the citrate-free formulation avoids this potential issue [ 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar

Gaylis,

Both,

Lemke

et al. 2024

Adv Ther

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Introduction Hyrimoz ® , (GP2017 [SDZ-ADL]), is a biosimilar to Humira ® (REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL. Totality of Evidence—the approach Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation. Evidence of biosimilarity Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL’s efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL. Conclusion Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.

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Section: Introductionmentioning

confidence: 99%

‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar

Gaylis,

Both,

Lemke

et al. 2024

Adv Ther

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“…60 Patients reported less injection pain with the citrate-free formula compared with the citrate-containing formula. 61 However, some adalimumab biosimilars, such as Imraldi, contain citrate to improve the stability of the product at room temperature. 15 For professionals in charge of selecting a biosimilar for clinical practice, factors like the drug formulation and injection device should be considered when selecting a biosimilar.…”

Section: Selecting a Biosimilar For Clinical Carementioning

confidence: 99%

TNFα inhibitor treatment trajectories

Meijboom

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Patients with immune-mediated inflammatory diseases, such as rheumatic diseases or inflammatory bowel disease are commonly treated with a type of medicine called Tumour Necrosis Factor (TNF) α inhibitors. The therapeutic effect of these TNFα inhibitors can vary between patients. Thus, patients often need to switch to a different treatment. In our thesis we showed that about 17% of IMID patients switch treatment, mainly due to loss of effect. As TNFα inhibitors are costly therapies, transitioning patients to a biosimilar (different brand name, same active ingredient), is a good option for cost containment. We found that several European medical associations have guidelines on transitioning patients from the original TNFα inhibitor (originator) to biosimilar. We found that one in six patients who transitioned from originator TNFα inhibitor to the biosimilar subsequently retransitioned to the originator (stopped biosimilar and restarted originator). Despite originators and biosimilars being similar in terms of efficacy and safety, these patients experienced loss of therapeutic effect and/or side effects from the biosimilar. We found that several factors might affect the number of patients retransitioning, such as the disease severity of the patients and extra monitoring to patients during transitioning. Patients who retransitioned had a more than threefold risk of stopping their originator treatment, indicating that they are still not satisfactorily treated after retransitioning. Patients mentioned that they missed autonomy in transitioning to the biosimilar, and they felt like their hospital prioritised finances over their wellbeing. These findings provide several strategies for improving biosimilar implementation in clinical practice, such as careful selection of a biosimilar, increasing trust in biosimilars, providing follow-up care to transitioned patients and accepting a certain proportion of patients retransitioning.

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Clinical experience of using biosimilars in Crohn’s disease and their effectiveness

Sequier,

Caron,

Danese

et al. 2024

Expert Opinion on Biological Therapy

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A Systematic Literature Review of Injection Site Pain Perception in Adult Patients Treated with Citrate-Free and Citrate-Containing Biologic Agents

Cited by 5 publications

References 37 publications

‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar

‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar

TNFα inhibitor treatment trajectories

Clinical experience of using biosimilars in Crohn’s disease and their effectiveness

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