Real Life Switching from Infliximab Innovator to Biosimilar in Rheumatic Diseases: A 6-Month Single-Centre Prospective Observational Study

Anjum, Aqeel; Wl, Ng; Sebastian, Agata; Devlin, Joe; Fraser, Alexander

doi:10.26502/fjr.26880011

Cited by 3 publications

(2 citation statements)

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“…As for the postulated risk of immunogenicity, switching to biosimilars was not considered a significant risk of immunogenicity, especially if it is a single switch that is conducted under medical supervision. This agrees with the body of evidence from both controlled trials [ 41 – 44 ] and real-world evidence [ 41 , 43 , 44 ]. Such beliefs and associated evidence should be communicated with prescribers to address their concerns about the safety of biosimilars to encourage them to use biosimilars for their patients, especially in countries where the need for them is high, and biosimilars’ use is still uncommon.…”

Section: Discussionsupporting

confidence: 90%

Maximizing the benefits of using biosimilars in Egypt

Fasseeh,

Elezbawy,

El-Fass

et al. 2023

J of Pharm Policy and Pract

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Background Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts. Methods A narrative literature review was conducted to identify biosimilars’ policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations. Results The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30–40% less than its originator’s price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary. Conclusions A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.

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Section: Discussionsupporting

confidence: 90%

Maximizing the benefits of using biosimilars in Egypt

Fasseeh,

Elezbawy,

El-Fass

et al. 2023

J of Pharm Policy and Pract

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“…Retention rates were also comparable between inflectra and remicade; this study confirmed that CT-P13 is a safe and efficacious option. 89 Rheumatoid arthritis study with various parameter calculations was given by Kim et al 90 in 2020, where DAS28-erythrocyte sedimentation rate, DAS28-CRP and ACR responses were analyzed for 199 rheumatoid arthritis patients with CT-P13 (n = 147) and reference infliximab (n = 52). However, some changes in treatment were made, where CT-P13 demonstrated improvements over reference infliximab, as seen from the data.…”

Section: Prospective Role Of Ct-p13 In Rheumatoid Arthritismentioning

confidence: 99%

Clinical Benefits of Switching from Original Infliximab to its Biosimilar (CT-P13) as a Potential TNF-α Inhibitor

Kumari¹,

Prasad²,

Kumar³

et al. 2020

Journal of Exploratory Research in Pharmacology

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Tumor necrosis factor-alpha (TNF-α) is implicated in the process of various autoimmune and inflammatory diseases through binding to its receptor, the tumor necrosis factor receptor. Nowadays, monoclonal anti-TNF-α antibody is used for the treatment of these diseases because it can neutralize TNF-α to block the relevant signaling responsible for the pathogenesis of these diseases. Currently, such antibody-based therapies have been demonstrated to be effective in controlling rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis. Infliximab is the first monoclonal antibody for the treatment of rheumatoid arthritis and has been approved for the intervention of other autoimmune and inflammatory diseases in the clinic. Although infliximab is considered highly efficacious, more so than common medications such as methotrexate and calcipotriol, its potential disadvantages, including loss of response in some patients, drug-related adverse events and particularly high cost, have motivated chemists and researchers to shift towards its biosimilar, CT-P13. CT-P13 has a better tolerance and much less cost, attracting more attention. Here, we summarize the clinical findings of CT-P13 from clinical trials in various diseases.

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