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Biosimilars crohn's

Massimo Radin, Savino Sciascia, Dario Roccatello, Maria Jose Cuadrado
BACKGROUND: Biological therapies represent a fundamental innovation for the management of inflammatory bowel diseases (IBD). However, many biological originators have reached, or are about to reach, patent expiry and long-term therapy costs have become progressively unsustainable. CT-P13, a biosimilar of the anti-tumor necrosis factor (anti-TNF) monoclonal antibody infliximab, might represent a significant alternative to its originator, with the potential to decrease medical care costs and, therefore, become available to a large number of patients...
December 29, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Ira Jacobs, Danielle Petersel, Leah Isakov, Sadiq Lula, K Lea Sewell
BACKGROUND: Clinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications. OBJECTIVES: The objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases. METHODS: MEDLINE(®), EMBASE(®), and ISI Web of Science(®) were searched to September 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Laura Martelli, Laurent Peyrin-Biroulet
BACKGROUND: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD...
October 14, 2016: Current Medicinal Chemistry
B Siegmund, R Atreya, B Bokemeyer, W Kruis, J Mudter, C Sander, S Schreiber, W Reindl, S Zeissig, T Kucharzik
After the expiry date of the patent protection for Infliximab in 2013, the biosimilar CT‑P13 was approved for indications in Crohn's disease and ulcerative colitis in adults as well as in children. The approval has been based on two randomized clinical studies indicating equivalence for the biosimilar with regard to pharmacokinetics, efficacy, as well as side-effects. The clinical experience since, in addition to multiple non-randomized studies, indicate a comparable efficacy and immunogenicity of the Infliximab biosimilar CT-P13 in inflammatory bowel disease...
November 2016: Zeitschrift Für Gastroenterologie
Lydia C T Buer, Bjørn A Moum, Milada Cvancarova, David J Warren, Asle W Medhus, Marte Lie Høivik
BACKGROUND AND AIMS: A biosimilar version of infliximab [CT-P13/Remsima®] recently entered the European market. The clinical data on its use in inflammatory bowel disease [IBD] are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population. METHODS: All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima...
September 22, 2016: Journal of Crohn's & Colitis
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Silvio Danese, Elmer Schabel, Johan Masure, Scott Plevy, Stefan Schreiber
The role of placebo in clinical trials for drug development in inflammatory bowel disease [IBD] was the topic of a panel discussion held during the 10th Congress of the European Crohn's and Colitis Organisation [ECCO], in Barcelona, Spain, in 2015. Panellists discussed a number of issues around placebo-controlled trials in IBD, noting issues such as difficulties with recruitment, leading to less then representative patient populations in clinical studies. It was noted that, whereas the easiest answer may be to drop placebo, it is much more complicated than that...
September 2016: Journal of Crohn's & Colitis
Marina Kostić, Ljiljan Djakovic, Raša Šujić, Brian Godman, Slobodan M Janković
BACKGROUND: Although the costs of treating inflammatory bowel disease (IBD) in developed countries are well established, they remain largely unknown in countries with recent histories of socio-economic transition including Serbia. OBJECTIVE: To estimate the costs of treatment including the resources used by patients with IBD in Serbia from a societal perspective. This includes both Crohn's disease and ulcerative colitis. METHODS: This cost-of-illness study was conducted to identify direct, indirect and out-of-pocket costs of treating patients with IBD in Serbia...
September 1, 2016: Applied Health Economics and Health Policy
M Severs, B Oldenburg, A A van Bodegraven, P D Siersema, M-J J Mangen
OBJECTIVE: Inflammatory bowel disease (IBD) entails a high economic burden to society. We aimed to estimate the current and future impact of the introduction of biosimilars for infliximab on IBD-related healthcare costs. DESIGN: We designed a stochastic economic model to simulate the introduction of biosimilars in IBD, using a five year time horizon, based on the Dutch situation. Prevalence data on ulcerative colitis (UC) and Crohn's disease (CD) and IBD-related healthcare costs data were used as input...
August 29, 2016: Journal of Crohn's & Colitis
Christina Y Ha, Asher Kornbluth
On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc...
October 2016: Inflammatory Bowel Diseases
Maurizio Benucci, Francesca Li Gobbi, Francesca Bandinelli, Arianna Damiani, Maria Infantino, Valentina Grossi, Mariangela Manfredi, Simone Parisi, Enrico Fusaro, Alberto Batticciotto, Piercarlo Sarzi-Puttini, Fabiola Atzeni, Francesca Meacci
Biosimilar infliximab (INX) was recently approved by the European Medicine Agency for the treatment of rheumatoid arthritis, ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis, psoriatic arthritis (PsA), and psoriasis on the grounds that its pharmacokinetics, safety, and efficacy were comparable to those of innovator INX. The aim of this study was to investigate the real-life efficacy, safety, and immunogenicity of switching from innovator to biosimilar INX in patients with spondyloarthritis (SpA)...
July 23, 2016: Immunologic Research
Lieven Pouillon, Peter Bossuyt, Laurent Peyrin-Biroulet
INTRODUCTION: Crohn's disease (CD) and ulcerative colitis (UC) are chronic disabling conditions. Monoclonal antibody therapy directed against tumor necrosis factor-alpha (anti-TNF) has revolutionized the care of patients with inflammatory bowel disease (IBD). AREAS COVERED: Considerations before starting anti-TNF therapy are highlighted: the best time to start with anti-TNF therapy, either alone or in combination with an immunomodulator, the choice of an anti-TNF agent and the contra-indications to anti-TNF therapy...
October 2016: Expert Opinion on Biological Therapy
Ira Jacobs, Ena Singh, K Lea Sewell, Ahmad Al-Sabbagh, Lesley G Shane
OBJECTIVE: To understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients' willingness to try a biosimilar. METHODS: An international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned...
2016: Patient Preference and Adherence
Shomron Ben-Horin, Niels Vande Casteele, Stefan Schreiber, Peter Laszlo Lakatos
Biologic drugs such as infliximab and other anti-tumor necrosis factor monoclonal antibodies have transformed the treatment of immune-mediated inflammatory conditions such as Crohn's disease and ulcerative colitis (collectively known as inflammatory bowel disease [IBD]). However, the complex manufacturing processes involved in producing these drugs mean their use in clinical practice is expensive. Recent or impending expiration of patents for several biologics has led to development of biosimilar versions of these drugs, with the aim of providing substantial cost savings and increased accessibility to treatment...
December 2016: Clinical Gastroenterology and Hepatology
Marcin Włodarczyk, Jakub Fichna, Aleksandra Sobolewska-Włodarczyk
Biological therapy with monoclonal antibodies to tumor necrosis factor alpha (TNF-α) was shown in large clinical trials to be effective in inducing and maintaining clinical remission in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). Infliximab, the first anti-TNF-α biologic drug, has significantly improved inflammatory bowel disease (IBD) treatment outcomes by preventing structural damage progression, thereby reducing complications and the need for surgery and hospitalization...
August 2016: Pharmacological Reports: PR
Silvio Danese, Gionata Fiorino, Pierre Michetti
BACKGROUND: In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists' thinking about biosimilars one year after they had become available in the European Union. METHODS: A 14-question anonymous survey was posted on the ECCO website. Members voluntarily responded in response to ECCO office invitations to participate in their surveys. Information on gender, job position, country, and experience with biologics also were collected...
November 2016: Journal of Crohn's & Colitis
Lisa J T Smits, Lauranne A A P Derikx, Dirk J de Jong, Ronald S Boshuizen, Aura A J van Esch, Joost P H Drenth, Frank Hoentjen
BACKGROUND AND AIMS: The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients. METHODS: Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study...
November 2016: Journal of Crohn's & Colitis
Radan Keil, Martin Wasserbauer, Zdena Zádorová, Jan Hajer, Pavel Drastich, Pavel Wohl, Marek Beneš, Martina Bojková, Pavel Svoboda, Michal Konečný, Přemysl Falt, Tomáš Vaňásek, Martin Pešta, František Pešek, Luděk Bouchner, Jana Koželuhová, Aleš Novotný, Lucie Bartůsková, Julius Špičák
OBJECTIVE: The infliximab biosimilar CT-P13 (Remsima(®), Inflectra(®)) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn's disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic...
September 2016: Scandinavian Journal of Gastroenterology
Ewa Olech
OBJECTIVES: To discuss current terminology and the regulatory standards and processes involved in the development of biosimilars. METHODS: An Internet-based literature search through April 2015 was performed for information related to biosimilars in chronic inflammatory disorders. Keywords were as follows: biosimilar, development, manufacturing, characterization, structural, functional, preclinical, clinical, immunogenicity, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn׳s disease, ulcerative colitis, and ankylosing spondylitis...
April 2016: Seminars in Arthritis and Rheumatism
Douglas C Wolf
No abstract text is available yet for this article.
April 2016: Inflammatory Bowel Diseases
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