The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis

Kaniewska, Magdalena; Moniuszko, Andrzej; Rydzewska, Grażyna

doi:10.5114/pg.2017.70468

Cited by 21 publications

(17 citation statements)

References 20 publications

(28 reference statements)

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“…Moreover, it revealed that the reference and biosimilar drugs had similar clinical efficacy and safety. During 1-year of follow-up after the end of treatment, a similar relapse rate was observed between groups [16]. Another study included 286 patients with CD referred for 1-year treatment with originator infliximab, biosimilar infliximab, or originator adalimumab.…”

Section: Switching Between a Reference Product And A Biosimilarmentioning

confidence: 52%

Biosimilar biological drugs in the treatment of inflammatory bowel diseases

Kaniewska

Eder

Gąsiorowska

et al. 2019

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Within the last 20 years, tumour necrosis factor inhibitors have been proven to be effective in achieving and maintaining clinical and endoscopic remission in patients with Crohn's disease and ulcerative colitis. Since 2013, when infliximab originator lost its patent protection, patients with inflammatory bowel diseases (IBDs) in Poland have also been treated with biosimilar drugs. Biosimilars are drugs with high similarity to their reference products in terms of physicochemical properties, including structure, safety, and efficacy. Biosimilars are approved for use on the basis of the same rigorous quality standards as their reference products. In 2018, also biosimilars of adalimumab have become available. Studies published to date have shown that biosimilars do not differ from reference drugs in terms of the efficacy and safety. There are numerous data to confirm that a single switch of biological drugs (mainly from reference to biosimilar drugs) has no effect on therapy efficacy and safety. However, a significantly lower cost of therapy with biosimilars not only allows us to treat a much larger number of patients but may also necessitate multiple switches from reference drugs to biosimilars (including biosimilars produced by different manufacturers). Recently, the first results have been published concerning multiple switches in patients with psoriasis and rheumatoid arthritis. However, no such data are currently available for patients with IBDs.

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Section: Switching Between a Reference Product And A Biosimilarmentioning

confidence: 52%

Biosimilar biological drugs in the treatment of inflammatory bowel diseases

Kaniewska

Eder

Gąsiorowska

et al. 2019

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“…Most of these studies have evaluated the effects of the switch from infliximab originator to its biosimilars, revealing no safety or efficacy concerns [ 61 – 63 ]. Those studies that have compared the safety profile of originator and biosimilars have showed a similar rate of ADRs [ 64 , 65 ], but to our knowledge, no study has yet compared the rate of occurrence of infections, loss of efficacy or infusion reactions. However, available studies suggest that infliximab biosimilars, along with Remicade ® , can be associated with the occurrence of such ADRs [ 66 – 68 ].…”

Section: Discussionmentioning

confidence: 99%

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

et al. 2018

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BackgroundIn recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hypersensitivity reactions, and loss of efficacy, as a direct consequence of immunogenicity. Therefore, specific contraindications, special warnings and precautions have been introduced in the infliximab Summary of Product Characteristics (SPC).ObjectiveThe aim was to assess the magnitude of preventable ADRs in individual case safety reports (ICSRs) having infliximab as a suspected drug across Italy (using the spontaneous reporting systems), and the probability of reporting infections, infusion reactions, lack of efficacy, and hypersensitivity for originator and biosimilars of infliximab.MethodsWe analyzed ADRs reported across the 2015–2017 period in the databases of five Italian regions: Campania, Lombardy, Sicily, Tuscany, and Veneto. Preventability of ADRs was assessed using the P-method. To compare the probability of reporting infections, infusion reactions, lack of efficacy, and hypersensitivity as ADRs as opposed to other types of ADRs between originator and biosimilars of infliximab, we used the reporting odds ratio (ROR). For descriptive purposes, the number of ICSRs involving infliximab, the number of infliximab vials distributed in the aforementioned Italian regions and the relative reporting rate stratified by semester were reported.ResultsFrom October 2015 to October 2017, 459 ICSRs reported infliximab as a suspected drug (222 ICSRs related to infliximab originator and 237 to infliximab biosimilars). In the same period, 81,906 vials of infliximab were distributed, resulting in a reporting rate of six ICSRs/1000 vials. Overall, 34 cases (7.41%) were categorized as preventable. The most frequently detected critical criteria were “documented hypersensitivity to administered drug or drug class,” “inappropriate prescription for patient’s underlying medical condition” and “incorrect dose.” Biosimilars had, in adjusted analyses, an increased probability of being reported as suspected in ICSRs reporting infusion reactions (ROR 4.09; 95% confidence interval [CI] 1.26–13.32) when compared to Remicade®. On the contrary, they had a decreased probability of being reported as suspected in ICSRs reporting infections or lack of efficacy (ROR 0.33; 95% CI 0.12–0.89; ROR 0.35; 95% CI 0.20–0.61).ConclusionOur study demonstrates that, along with a rapid increase in the utilization of infliximab biosimilars across Italy, there was also an increase in reporting ADRs induced by infliximab biosimilars. Of the reported ADRs, 7.4% were considered preventable. In adjusted analyses, infliximab biosimilars were shown to have ...

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“…A total of 29 studies (Table 1) assessing switching from IFX originator to biosimilar CT-P13 22–50 and 14 assessing induction therapy with IFX-B CT-P13 were found. 32,39,43,46,51–60…”

Section: Introductionmentioning

confidence: 99%

Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective

Milassin

Fábián

Molnár

2019

Therap Adv Gastroenterol

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Background: Biological therapy has revolutionized the treatment of inflammatory bowel disease (IBD). After the expiration of patents for biological innovator products, development of biosimilars increased. CT-P13 was the first biosimilar approved for the same indications as the reference product; however, the approval was based on extrapolated data from rheumatoid arthritis and ankylosing spondylitis. Our aim was to review clinical studies about switching from originator infliximab (IFX-O) to biosimilar infliximab (IXF-B) in IBD, focusing on recently published data and the future of biosimilars. Methods: The PubMed database was searched for original articles published up to 1 December 2018 reporting data on IFX-B in IBD. Results: A total of 29 studies assessing switching from IFX-O to IFX-B, 14 assessing induction therapy with IFX-B were found. Efficacy, safety and immunogenicity were discussed. Studies confirm that CT-P13 is safe and equally efficient as the reference product for both induction and maintenance therapy; and that switching from the reference product to biosimilar is non-inferior to continuous biosimilar use. However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking. Conclusion: Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.

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The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis

Cited by 21 publications

References 20 publications

Biosimilar biological drugs in the treatment of inflammatory bowel diseases

Biosimilar biological drugs in the treatment of inflammatory bowel diseases

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective

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