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Dae Hyun Yoo, Jung-Yoon Choe, Seung Cheol Shim, Chang-Hee Suh
For successful switching of bio-originators to biosimilars, confidence in the switch is an important criterion. To promote confidence, scientific evidence is critical, but still there are insufficient data for the majority of approved biosimilars. Areas covered: Scientific evidence for switching from bio-originator DMARDs to biosimilars is derived from randomized controlled trials (RCTs) for switching, extension studies of RCTs for the approval process, and real-world observational studies. To identify candidate studies, PubMed was searched to collect appropriate studies in all approved biosimilars for the treatment of rheumatic diseases...
June 18, 2018: Expert Review of Clinical Immunology
María Fernanda Guerra Veloz, Juan María Vázquez Morón, María Belvis Jiménez, Héctor Pallarés Manrique, Teresa Valdés Delgado, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldán, Raúl Perea Amarillo, Vicente Merino, Ángel Caunedo Álvarez, Federico Argüelles Arias
BACKGROUND AND AIMS: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. METHODS: this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC)...
June 12, 2018: Revista Española de Enfermedades Digestivas
J Goncalves, M Santos, R Acurcio, I Iria, L Gouveia, P Matos Brito, A Catarina Cunha-Santos, A Barbas, J Galvão, I Barbosa, F Aires da Silva, A Alcobia, M Cavaco, M Cardoso, J Delgado Alves, J J Carey, T Dörner, J Eurico Fonseca, C Palmela, J Torres, C Lima Vieira, D Trabuco, G Fiorino, A Strik, M Yavzori, I Rosa, L Correia, F Magro, G D'Haens, S Ben-Horin, P Lakatos, S Danese
AIM: To test the cross-immunogenicity of anti-CT-P13 IBD patients' sera to CT-P13/infliximab originator and the comparative antigenicity evoked by CT-P13/infliximab originator sera. METHODS: Sera of patients with IBD with measurable anti-CT-P13 antibodies were tested for their cross-reactivity to 5 batches of infliximab originator and CT-P13. Anti-drug antibody positive sera from treated patients were used to compare antigenic epitopes. RESULTS: All 42 anti-CT-P13 and 37 anti-infliximab originator IBD sera were cross-reactive with infliximab originator and CT-P13 respectively...
June 5, 2018: Alimentary Pharmacology & Therapeutics
Silvio Danese, Gionata Fiorino
Biosimilars of infliximab (CT-P13) are currently approved and available for the same indications as the originator. Some concerns about safety and immunogenicity have risen in the past because of lack of data in IBD. Since 2015, several cohort studies have been conducted in IBD showing that CT-P13 has comparable safety and efficacy profile to the originator, both in adult and pediatric population, either in naïve patients, or even in those who switched from the originator to CT-P13. This review aims to analyze the current literature data in order to define a clear patient profile, to identify those IBD patients who would benefit the most from the use of CT-P13...
May 13, 2018: Current Medicinal Chemistry
Javier P Gisbert, María Chaparro
AIM: To review the effectiveness and safety of switching from an originator anti-TNF (Remicade® ) to a biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD). METHODS: Electronic and manual search up to September 2017. RESULTS: We identified 24 studies evaluating switching between Remicade® and CT-P13 in 1326 patients. Disease control (no worsening after switching) was confirmed in most of the patients (weighted mean, 88%; 95% CI=86-89%)...
May 9, 2018: Gastroenterología y Hepatología
Zsuzsanna Kurti, Lorant Gonczi, Peter L Lakatos
Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected. Biosimilars represent less expensive alternatives compared to the reference product. Areas covered: In this review, authors will review the literature on the clinical efficacy, safety and immunogenicity of current and future biosimilar infliximabs...
June 2018: Expert Opinion on Biological Therapy
Raguprakash Ratnakumaran, Natalie To, David J Gracie, Christian P Selinger, Anthony O'Connor, Tanya Clark, Nicola Carey, Katherine Leigh, Lynsey Bourner, Alexander C Ford, P John Hamlin
OBJECTIVES: Recently, the infliximab biosimilar (CT-P13) received market authorisation for inflammatory bowel disease (IBD), allowing cost benefits when switching to CT-P13. We aim to assess the efficacy and safety of switching from originator infliximab to CT-P13 for new and existing patients. MATERIAL AND METHODS: Treatment response, remission, primary and secondary loss of response rates, and adverse events in patients who initiated infliximab originator in the 12 months pre-switch (n = 53) were compared with the patients who initiated CT-P13 in the 12 months post-switch (n = 69)...
April 24, 2018: Scandinavian Journal of Gastroenterology
A Mayoral-Zavala, A Esquivel-Aguilar, C M Del Real-Calzada, Y Gutiérrez-Grobe, J Ramos-García, J L Rocha-Ramírez, M F Rojas-Illanes, B Rubio-Martínez, X Sánchez-Chávez, J K Yamamoto-Furusho
The biotechnology-derived medicines known as biosimilars are defined as non-originator treatments that have demonstrated quality, efficacy, and safety comparable to the reference biologic drug. Clinical trials have shown that the infliximab biosimilar, CT-P13, and the candidates for the adalimumab biosimilars, ABP 501 and ZRC 3197, are not significantly different, with respect to efficacy and safety, from the originator drugs in patients with other autoimmune diseases. However, controversy has arisen over the use of biosimilars in inflammatory bowel disease, due to the incipient evidence not only in patients with no previous biotechnology treatment, but also in patients in remission, that could be switched to a biosimilar for non-medical reasons...
April 20, 2018: Revista de Gastroenterología de México
Stefanos Bonovas, Laurent Peyrin-Biroulet, Silvio Danese
No abstract text is available yet for this article.
June 2018: Lancet. Gastroenterology & Hepatology
Anne S Strik, Wim van de Vrie, Joanne P J Bloemsaat-Minekus, Michael Nurmohamed, Peter J J Bossuyt, Alexander Bodelier, Theo Rispens, Yvonne J B van Megen, Geert R D'Haens
BACKGROUND: Biological treatment of chronic inflammatory diseases has improved patient outcomes but increased health-care costs. Switching patients from originator infliximab to a biosimilar can reduce costs, but prospective data about pharmacokinetics and potential immunogenicity are scarce. We aimed to show that infliximab serum concentrations with biosimilar CT-P13 are non-inferior to those with originator infliximab after switching from originator infliximab in patients with inflammatory bowel disease...
June 2018: Lancet. Gastroenterology & Hepatology
Lisette Binkhorst, Annemieke Sobels, Rogier Stuyt, Elsbeth M Westerman, Rachel L West
OBJECTIVE: Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab. PATIENTS AND METHODS: At two large general hospitals in The Netherlands, adult patients with a diagnosis of Crohn's disease or ulcerative colitis being treated with Remicade were asked to switch to the biosimilar infliximab (CT-P13)...
March 13, 2018: European Journal of Gastroenterology & Hepatology
Federico Argüelles Arias, Joaquín Hinojosa Del Val, Isabel Vera Mendoza
In 2013, the European Medicines Agency (EMA) approved the biosimilar infliximab (CT-P13) for the full range of indications of the originator product, based on data from two trials conducted in rheumatoid arthritis and ankylosing spondylitis. The same year, our Society published a position statement that was later reviewed.
March 12, 2018: Revista Española de Enfermedades Digestivas
Konstantinos H Katsanos, Konstantinos Papamichael, Adam S Cheifetz, Dimitrios K Christodoulou
No abstract text is available yet for this article.
February 15, 2018: Inflammatory Bowel Diseases
Gionata Fiorino, M Begoña Ruiz-Argüello, Ainara Maguregui, Daniel Nagore, Carmen Correale, Simona Radice, Daniela Gilardi, Mariangela Allocca, Federica Furfaro, Antonio Martínez, Silvio Danese
Background: Infliximab (IFX) biosimilars CT-P13 and SB2 have comparable efficacy, safety, and immunogenicity to the originator Remicade (RMC). However, concerns about cross-switching patients between the 3 brands were raised in the absence of cross reactivity data between them. We aimed to determine whether antibodies to infliximab (ATI) in inflammatory bowel disease (IBD) patients cross-react with RMC, CT-P13, and SB2. Methods: Based on previous ATI status, samples from 34 patients participating in the BIOSIM01 study (13 RMC, 9 CT-P13, and 12 switchers) were selected...
February 15, 2018: Inflammatory Bowel Diseases
Tina D Mahajan, Ted R Mikuls
PURPOSE OF REVIEW: Therapies for rheumatoid arthritis (RA) continue to expand rapidly. The purpose of this review is to discuss novel treatment options, including biosimilars, that are available, as well as to highlight promising agents in development. The purpose is also to discuss new emerging safety signals associated with these drugs and to discuss strategies in tapering therapy. RECENT FINDINGS: There are several novel RA therapies. These include the interleukin-6 (IL-6) receptor blocker sarilumab, which was approved in 2017...
May 2018: Current Opinion in Rheumatology
Cătălin Codreanu, Klára Šírová, Katerina Jarošová, Anastas Batalov
OBJECTIVE: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS). METHODS: This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations...
April 16, 2018: Current Medical Research and Opinion
Ben Kang, Yoon Lee, Kiwuk Lee, Young Ok Choi, Yon Ho Choe
Background: The relatively high cost and patent expiry of infliximab, an anti-tumor necrosis factor monoclonal antibody used in inflammatory bowel disease (IBD), has led to the development of biosimilar versions of the reference product (RP). This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP in pediatric-onset IBD patients. Methods: In this prospective observational study, patients with pediatric-onset IBD receiving maintenance infliximab RP were followed for 1 year after continuing infliximab RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group)...
February 15, 2018: Inflammatory Bowel Diseases
B Glintborg, T Kringelbach, N Bolstad, D J Warren, G Eng, I J Sørensen, A G Loft, O Hendricks, Imj Hansen, A Linauskas, H Nordin, S Kristensen, H Lindegaard, D V Jensen, G L Goll, E Høgdall, J Gehin, C Enevold, C H Nielsen, N S Krogh, J S Johansen, M L Hetland
No abstract text is available yet for this article.
January 9, 2018: Scandinavian Journal of Rheumatology
A K Aarebrot, S M Solberg, R Davies, L I Bader, T D Holmes, S Gavasso, Y T Bryceson, R Jonsson, L F Sandvik, S Appel
BACKGROUND: Psoriasis vulgaris is a chronic, inflammatory skin disease characterized by a dysregulated immune response and it is associated with substantial systemic comorbidities. Biological drugs like tumor necrosis factor (TNF) inhibitors can ameliorate the disease but are expensive. Biosimilar drugs have the same amino acid sequence as the originator, but differences in manufacturing can affect biological activity, efficacy and tolerability. OBJECTIVES: We aimed to explore potential differences in intracellular phosphorylation of signaling molecules in peripheral blood cells from TNF inhibitor infliximab treated psoriasis patients compared to healthy controls, and to investigate if the phosphorylation pattern was influenced by switching from originator infliximab to biosimilar CT-P13...
December 23, 2017: British Journal of Dermatology
Valderilio Feijo Azevedo, Igor Age Kos, Leonardo Ariello
BACKGROUND: Infliximab biosimilars are the first biosimilars of monoclonal antibodies approved by the main regulatory agencies. Up to the present day, two infliximab biosimilars have been approved: CT-P13 (Celltrion), and SB2 (Biogen), but other companies have been developing candidate infliximab biosimilars that are on clinical trials: PF 06438179 (Pfizer), the ABP710 (bioCentury/Amgen) the BCD055 (JSC Biocad Russica) and BOW015 (Epirus). METHODS: We have made a literature search in MedLine database using the key words [Infliximab] and [biosimilars] and [rheumatic diseases] and [rheumatisms]...
2017: Current Pharmaceutical Design
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