Clinical development of biologicals and biosimilars - safety concerns

Bonovas, Stefanos; Peyrin–Biroulet, Laurent; Danese, Silvio

doi:10.1080/17512433.2017.1293522

Cited by 14 publications

(14 citation statements)

References 14 publications

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“…Biosimilar infliximab (CT-P13) was the first monoclonal antibody biosimilar approved in the European Union, and has also received regulatory approval in Australia, Canada, Japan, and the US 4 . Early clinical trials to demonstrate the therapeutic equivalence of biosimilar infliximab to reference infliximab were conducted in patients with ankylosing spondylitis and rheumatoid arthritis 5–8 .…”

Section: Introductionmentioning

confidence: 99%

“…Early clinical trials to demonstrate the therapeutic equivalence of biosimilar infliximab to reference infliximab were conducted in patients with ankylosing spondylitis and rheumatoid arthritis 5–8 . The results of these studies supported regulatory approval of biosimilar infliximab across all indications for which the parent biologic was approved, including inflammatory bowel disease (IBD) 4 . Additional observational data are, thus, required to confirm the risk:benefit profile of biosimilar infliximab in patients with IBD under everyday use in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Gheorghe

Svoboda

Mateescu

2019

Journal of Drug Assessment

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Objective: To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn’s disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn’s Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Results: Altogether, 85 patients with CD ( n = 38) or UC ( n = 47) received biosimilar infliximab for up to 30 weeks. Most patients ( n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8–78.9) of CD patients and 55.3% (95% CI = 41.2–68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5–62.7) and 48.9% (95% CI = 35.3–62.8), respectively, were in remission. Statistically significant ( p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved ( p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Conclusion: Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Gheorghe

Svoboda

Mateescu

2019

Journal of Drug Assessment

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“…Despite clear price differences between originator and biosimilar, the uptake of the latter was moderate, yet faster for the second biosimilar introduced (etanercept) than for the first (infliximab). Besides regional pricing agreements for infliximab that may have negatively impacted the economic incentive to switch, discussions of increased immunogenicity for infliximab, [10] and being the first biosimilar on the market, might explain the slower rate of non-medical switch. Small, or no, differences were observed in disease characteristics between patients starting the originator or the biosimilar, after stratification by line of therapy.…”

Section: Discussionmentioning

confidence: 99%

Uptake of rheumatology biosimilars in the absence of forced switching

Giuseppe

Frisell

Ernestam

et al. 2018

Expert Opinion on Biological Therapy

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Background: To describe the uptake and system-level effects of the introduction of biosimilars in a setting without forced switching. Research design and methods:We used data from the Swedish Rheumatology Quality register from start of marketing of infliximab (Remsima® and Inflectra®) and etanercept (Benepali®) biosimilars until December 31 st 2016. We compared users of each originator-product and its biosimilar(s) by line of treatment: bDMARD-naïve patients, non-medical switchers (vs. matched patients remaining on originator), and patients switching from a previous bDMARD of another type.

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“…A população alvo do presente estudo foi composta por pacientes que fizeram uso do infliximab referência no período de primeiro de janeiro de 2016 a 31 de dezembro de 2017, na operadora de plano de saúde onde desenvolveu-se a pesquisa. Avaliou-se a possível permuta entre o medicamento referência e seu biossimilar, visto a similaridade entre ambas nos termos de qualidade, segurança e eficácia 5 . Foram considerados como critérios de exclusão o pagamento indevido da tecnologia, não pagamento por critérios de auditoria e ainda glosas justificadas.…”

Section: Métodosunclassified

“…Os medicamentos biológicos vêm sendo utilizados para uma grande variedade de condições patológicas crônicas inflamatórias reumáticas 1 . Essas drogas vêm revolucionando as opções de tratamento para muitas doenças como a artrite reumatoide, psoríase, espondilite anquilosante, artrite psoriática, lúpus eritematoso sistêmico e doença de Crohn, podendo melhorar significativamente a qualidade de vida do paciente 5 . No entanto, os custos associados à produção desses medicamentos são cada vez maiores e limitam o acesso ao tratamento 6 -apenas nos Estados Unidos da América (EUA), no ano de 2016, foram estimados em cerca de US $ 350 bilhões 7 e, apesar de representarem menos de 1% de todas as receitas, eles equivalem a 28% do total de gastos com medicamentos naquele país 8 .…”

Section: Introductionunclassified

Custo-minimização da troca entre o medicamento referência seu biossimilar: sustentabilidade na relação tratamento vs. saúde suplementar

Ramires¹,

Oliveira²,

Sousa³

et al. 2022

JAFF

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Resumo: Objetivo: Avaliar custo-minimização da troca entre as versões referência e biossimilar (BSM) do infliximab (IFX) em operadora de saúde com mais de 500.000 vidas. Metodologia: Estudo retrospectivo, descritivo, seguido de custo-minimização entre os pacientes que utilizaram IFX, de 1º de janeiro de 2016 a 31 de dezembro de 2017. Avaliou-se possível permuta entre as drogas objetivando descrever a economia da substituição. Estabeleceram-se como critérios de exclusão o pagamento da tecnologia fora do protocolo estabelecido pela operadora, não pagamento e glosas justificadas. Após exclusão, calcularam-se as despesas totais somando os custos do produto, atualizados pelo Índice Nacional de Preços ao Consumidor Amplo (IPCA), e taxas de infusão. Resultados: Evidenciou-se que 185 pacientes, totalizando 1.441 liberações, utilizaram IFX referência no período avaliado. Destas, 31 liberações foram excluídas devido aos critérios estipulados. Por fim, 1.410 liberações foram incluídas. Identificou-se a utilização de 5.354 frascos de IFX referência, por 12 especialidades, totalizando

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Clinical development of biologicals and biosimilars - safety concerns

Cited by 14 publications

References 14 publications

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Uptake of rheumatology biosimilars in the absence of forced switching

Custo-minimização da troca entre o medicamento referência seu biossimilar: sustentabilidade na relação tratamento vs. saúde suplementar

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