Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product

Saleem, Ramsey A.; Cantin, Greg T.; Wikström, Mats; Bolton, Glen; Kuhns, Scott; McBride, Helen J.; Liu, Jennifer

doi:10.1007/s11095-020-02816-w

Cited by 14 publications

(18 citation statements)

References 36 publications

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“…Figure 3c, d demonstrate the similarity of ABP 710 with infliximab RP for in vitro effector function activities including ADCC and CDC. These functional assessments reflect on the key MoAs as they relate to activity in the treatment of IMIDs in general, and also reflect on the biological functions underlying efficacy in all indications for which infliximab RP is approved and which are complex and may not be the same for each indication [21,[33][34][35]. With the confirmation of similarity in analytical (structural and functional) characteristics, the development of ABP 710 advanced to the evaluation of clinical PK/pharmacodynamics (PD).…”

Section: Analytical Characterizationmentioning

confidence: 99%

“…When covariates identified to be predictive of ACR20 by a stratified conditional logistic regression were used to adjust for the impact of random imbalance between the two treatment arms in baseline demographic and disease characteristics, the resulting estimates of RD of ACR20 at week 22 and the associated 90% CIs were narrowed such that both the lower and upper bounds were contained within the prespecified equivalence margin. Further, additional efficacy endpoints including changes [21]. https://www.…”

Section: Clinical Evaluationmentioning

confidence: 99%

“…This allowed for the establishment of the scientific bridge which then allowed the use of a single source for the RP in the comparative clinical study. It is also important to note that while infliximab RP was developed using an SP2/0 murine cell line, ABP 710 was developed using a Chinese hamster ovary (CHO) cell line [ 21 ]. CHO cell lines are now generally regarded as the state-of-the-art choice with benefits supporting both development and manufacturing [ 22 ].…”

Section: Development Of Abp 710mentioning

confidence: 99%

“…To assess the analytical similarity of ABP 710 with infliximab RP, detailed identification and comparisons of critical quality attributes (CQAs) were used to evaluate similarity in biochemical and biophysical attributes. ABP 710 was demonstrated to be analytically similar to infliximab RP from both sources for assessments which included primary structure (intact molecular mass, reduced and deglycosylated molecular mass, amino acid sequence, and post-translational modifications [PTMs] including glycan structure), higher-order structure, particles and aggregates, product-related substances and impurities, and general properties including those of the finished drug product [ 21 ]. The overlays of the peptide and glycan maps depicted in Fig.…”

Section: Development Of Abp 710mentioning

confidence: 99%

“…1 a Reduced tryptic peptide map; b HILIC glycan map of ABP 710 and infliximab reference product (RP) sourced from the EU and US. Reproduced from Saleem et al [ 21 ]. https://www.creativecommons.org/licenses/by/4.0/ .…”

Section: Development Of Abp 710mentioning

confidence: 99%

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A Review of the Totality of Evidence for the Development and Approval of ABP 710 (AVSOLA), an Infliximab Biosimilar

et al. 2021

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ABP 710 (AVSOLA ® ) is a biosimilar to infliximab reference product (RP), a monoclonal antibody targeting tumor necrosis factor alpha (TNFα). It is approved in the USA and Canada for all the same indications as infliximab RP. Approval of ABP 710 was based on the totality of evidence (TOE) generated using a stepwise approach to assess its similarity with infliximab RP with regard to analytical (structural and functional) characteristics, pharmacokinetic parameters, and clinical efficacy and safety. ABP 710 was shown to be analytically similar to infliximab RP including in amino acid sequence, primary peptide structure, and glycan mapping and purity. ABP 710 was also demonstrated to be similar to infliximab RP with regard to functional characterization including in vitro binding, effector functions, and signaling pathways important for the mechanisms of action for clinical efficacy in multiple indications of immune-mediated inflammatory disorders including inflammatory bowel disease (IBD), especially binding to both soluble and membrane-bound TNFα. Pharmacokinetic similarity of ABP 710 with infliximab RP was demonstrated in healthy volunteers following a single 5 mg/kg intravenous dose. Comparative clinical efficacy of ABP 710 with infliximab RP was demonstrated in patients with rheumatoid arthritis. Safety and immunogenicity were also demonstrated to be similar for both ABP 710 and the RP. Overall, the TOE supported the conclusion that ABP 710 is highly similar to infliximab RP and supported scientific justification for extrapolation to all approved indications of infliximab RP, including IBD.

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Section: Analytical Characterizationmentioning

confidence: 99%

Section: Clinical Evaluationmentioning

confidence: 99%

Section: Development Of Abp 710mentioning

confidence: 99%

Section: Development Of Abp 710mentioning

confidence: 99%

Section: Development Of Abp 710mentioning

confidence: 99%

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A Review of the Totality of Evidence for the Development and Approval of ABP 710 (AVSOLA), an Infliximab Biosimilar

et al. 2021

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A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies

Guillén

Ekman

Barry

et al. 2022

Clin Pharma and Therapeutics

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Biosimilar monoclonal antibodies (mAbs) have been approved in the European Union since 2013 and have been demonstrated to reduce healthcare costs and to expand patient access. Biosimilarity is mainly established on the basis of demonstrated similarity of relevant quality attributes (QAs), determined by comprehensive physiochemical and functional analyses, and demonstration of bioequivalence. In addition, comparative efficacy/safety studies have been requested for all approved biosimilar mAbs so far, although the European Medicines Agency (EMA) Guidelines state that such confirmatory clinical trials may not be necessary in specific circumstances. In order to evaluate the degree of analytical similarity, how residual uncertainty regarding biosimilarity was resolved, and the value of clinical data, we analyzed the quality and clinical data packages for authorized adalimumab (7 products) and bevacizumab (5 products) biosimilars. The percentage of biosimilar batches meeting the similarity range for QAs, as defined by the biosimilar manufacturer based on a comprehensive characterization of the EU reference product (RP), was determined and clinical data were reviewed. Our analyses show that QAs of approved adalimumab and bevacizumab biosimilars have varying concordance with the EU‐RP similarity range. In this study, we found that clinical efficacy data played a limited role in addressing quality concerns. Therefore, we encourage a regulatory review of the standards for clinical data requirements for mAb and fusion protein biosimilars. This study outlines a quality data driven approach for facilitating tailored clinical programs for biosimilars.

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Infliximab microencapsulation: an innovative approach for intra-articular administration of biologics in the management of rheumatoid arthritis—in vitro evaluation

Lamela-Gómez

Gonçalves

Almeida

et al. 2023

Drug Deliv. and Transl. Res.

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Microencapsulation of the therapeutical monoclonal antibody infliximab (INF) was investigated as an innovative approach to improve its stability and to achieve formulations with convenient features for intra-articular administration. Ultrasonic atomization (UA), a novel alternative to microencapsulate labile drugs, was compared with the conventional emulsion/evaporation method (Em/Ev) using biodegradable polymers, specifically Polyactive® 1000PEOT70PBT30 [poly(ethylene-oxide-terephthalate)/poly(butylene-terephthalate); PEOT-PBT] and its polymeric blends with poly-(D, L-lactide-co-glycolide) (PLGA) RG502 and RG503 (PEOT-PBT:PLGA; 65:35). Six different formulations of spherical core–shell microcapsules were successfully developed and characterized. The UA method achieved a significantly higher encapsulation efficiency (69.7–80.25%) than Em/Ev (17.3–23.0%). Mean particle size, strongly determined by the microencapsulation method and to a lesser extent by polymeric composition, ranged from 26.6 to 49.9 µm for UA and 1.5–2.1 µm for Em/Ev. All formulations demonstrated sustained INF release in vitro for up to 24 days, with release rates modulated by polymeric composition and microencapsulation technique. Both methods preserved INF biological activity, with microencapsulated INF showing higher efficacy than commercial formulations at comparable doses regarding bioactive tumor necrosis factor-alpha (TNF-α) neutralization according to WEHI-13VAR bioassay. Microparticles’ biocompatibility and extensive internalization by THP-1-derived macrophages was demonstrated. Furthermore, high in vitro anti-inflammatory activity was achieved after treatment of THP-1 cells with INF-loaded microcapsules, significatively reducing in vitro production of TNF-α and interleucine-6 (Il-6). Graphical Abstract

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Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product

Cited by 14 publications

References 36 publications

A Review of the Totality of Evidence for the Development and Approval of ABP 710 (AVSOLA), an Infliximab Biosimilar

A Review of the Totality of Evidence for the Development and Approval of ABP 710 (AVSOLA), an Infliximab Biosimilar

A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies

Infliximab microencapsulation: an innovative approach for intra-articular administration of biologics in the management of rheumatoid arthritis—in vitro evaluation

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