Is it time for biosimilars in autoimmune diseases?

Cuadrado, M J; Sciascia, Savino; Bosch, Xavier; Khamashta, Munther A.; Ramos-Casals, Manuel

doi:10.1016/j.autrev.2013.02.005

Cited by 19 publications

(6 citation statements)

References 18 publications

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“…Despite their clinical benefits, cost remains a concern for biologic treatments, especially in countries like India that need to cater to a large, non‐insured patient pool with financial constraints . Biosimilars have, thus, emerged and compensated the cost burden and growing demand for originator biologics combined with their patent expiration . ZRC‐3197 (Exemptia; Cadila Healthcare Ltd.) is one such biosimilar adalimumab (bADA) developed and first approved by Indian regulators .…”

Section: Introductionmentioning

confidence: 99%

Real‐life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data

Kapoor

Kaushik²,

Jain³

et al. 2019

ACR Open Rheumatology

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ObjectiveAdalimumab is a well‐established anti–tumor necrosis factor therapy for patients with ankylosing spondylitis (AS). An indigenously developed biosimilar adalimumab (bADA) (ZRC‐3197; Exemptia) is approved for prescribing in India. In this article, we present the effectiveness and tolerability of this bADA in real‐life Indian patients with AS from the Adalimumab Biosimilar Patient Registry (ASPIRE) (ISRCTN: 16838474).MethodsASPIRE is a postmarketing observational registry for evaluating the real‐world experiences of patients with autoimmune inflammatory disorders across multiple centers in India who were prescribed 40 mg of Exemptia subcutaneously every fortnight. For this report, data available until 24 weeks of bADA treatment for patients with AS who were included in the registry were evaluated.ResultsData from 308 patients with AS from the registry (median age of 35.0 [range 17‐68] years, 19% women) were analyzed. In analyzable patients with complete data, there was a gradual and significant decrease (P < 0.001) in the primary disease outcome scores (the mean Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score [n = 107] improved from 6.2 ± 1.54 to 2.1 ± 0.64, and the median visual analogue scale [VAS] score [n = 101] improved from 8 to 2) after 24 weeks of bADA therapy. BASDAI score was lower than 4 in about 94% of patients after 24 weeks of therapy, and 95% of patients achieved BASDAI50 response. The overall global assessment for efficacy and tolerability was ‘good’ to ‘excellent’ for a majority of the patients (≥98%), as rated by physicians as well as patients. The therapy was tolerated well, and there were no new unexpected adverse reactions with the biosimilar's use during this study.ConclusionThis report demonstrates the tolerability and effectiveness of bADA (Exemptia) after its clinical use for 24 weeks in real‐world patients with AS from Indian clinical practice.

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Section: Introductionmentioning

confidence: 99%

Real‐life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data

Kapoor

Kaushik²,

Jain³

et al. 2019

ACR Open Rheumatology

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“…Treatment targeted to B-cell response seems a rational approach, which has been reported in small cohorts and is now being tested in randomized trials. Lastly, there are significant cost implications with the use of rituximab as induction and/or maintenance therapy, but with the expiration of patent and the development of many bio-similars, as well as the possible use of lower doses adjusted to B-cell levels, the cost will be driven down [60]. …”

Section: Discussionmentioning

confidence: 99%

Update on Rituximab: An Established Treatment for All Immune-Mediated Kidney Diseases?

Evans

Salama²

2014

Nephron Clin Pract

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Rituximab, a monoclonal antibody directed against the CD20 antigen, found on certain B-cell subsets, results in significant B-cell depletion and has been increasingly used in immune-mediated renal disease and transplantation. Although originally applied to what were considered antibody-mediated diseases, it has become clear that auto- and alloreactive B cells contribute in many ways to immune dysfunction, and the benefit of B-cell depletion extends beyond reduction in auto- or alloantibody levels. Most positive data regarding the benefit of rituximab in immune-mediated kidney disease have come from uncontrolled cohort studies, with the only positive controlled clinical trials demonstrating efficacy for the treatment of systemic vasculitis. While negative trials may have potentially missed clinical effects due to trial design, there may be significant differences in responses in different diseases or lack of efficacy due to therapeutic overlap when used with certain drug combinations. Rituximab is a novel treatment that provides a clear alternative for patients in different clinical situations, and allows for customization of therapy. However, much remains to be understood as to how best to use it in a cost-effective manner, when not to use it, and what the long-term impact of therapy may be.

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“…The development of biosimilars has helped to offset the nancial burden and meet the rising demand for original biologics as well as the upcoming patent expiration. 9,10 The present study is intended to compare the e cacy, pharmacokinetics (PK), immunogenicity, safety, and tolerability of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. with iADA in subjects with active AS.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

Chandrashekara¹,

Parida²,

Sonawale

et al. 2023

Preprint

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Objectives To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. with innovator adalimumab (iADA, HUMIRA®) in subjects with active ankylosing spondylitis (AS). Methods The prospective, multicenter, randomized, double-blind, phase III study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e.,125 subjects in biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects received both the investigational products at a dose of 40 mg subcutaneously (pre-filled syringe contained 40 mg adalimumab in 0.4 ml as the active ingredient) every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, ECG, anti-adalimumab antibody (ADA) assessment, and laboratory tests. Results At 12 weeks, the ASAS 20/40/70 responses were achieved by 97.5%, 94.1%, and 68.9% patients who received biosimilar injection as compared to 98.4%, 96.7%, and 77% patients in iADA arm. Safety assessment showed that 19 (15.2%) subjects reported 33 AEs in the biosimilar adalimumab arm and 8 (11.9%) subjects reported 11 AEs in iADA arm. ADA for positive and negative subjects was statistically non-significant (P 0.3516) between the two arms. Conclusion The ASAS 20/40/70 response rates at week 12 were equivalent between patients treated with biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd and those treated with iADA. Both the drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry- India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration no: no. CTRI/2020/09/028070

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Is it time for biosimilars in autoimmune diseases?

Cited by 19 publications

References 18 publications

Real‐life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data

Real‐life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data

Update on Rituximab: An Established Treatment for All Immune-Mediated Kidney Diseases?

Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

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