February 15th 2025
Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.
January 31st 2025
Biosimilars Benefit Patients With Expanded Access, but Physicians Still Need Education
March 29th 2019Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.
New Research Assesses Factors That May Impact Adalimumab Therapy in IBD
March 8th 2019During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).
Investigators Present Data on ADA Development, TDM for Biosimilar Adalimumab
March 6th 2019The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.
Studies Investigate Drug Survival, Discontinuation of Biologics in IBD
March 5th 2019In patients with ulcerative colitis and Crohn disease, treatment with biologics is often effective, but adverse events or loss of response may lead to discontinuation. Several studies that will be presented at this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, sought to investigate factors related drug survival and discontinuation of biologic therapies for inflammatory bowel disease (IBD).
Researchers Present Findings on Switching to CT-P13 in IBD
March 4th 2019This week, the European Crohn’s and Colitis Organisation (ECCO) will hold its 14th Congress in Copenhagen, Denmark. During the meeting, which runs from March 6-9, experts will gather from around the globe to discuss significant medical research into the treatment of inflammatory bowel disease (IBD), and numerous researchers will present findings on real-world switches to biosimilar infliximab CT-P13 (Inflectra, Remsima).
CT-P13 in IBD Is Safe and Effective in the Long Term, Research Shows
February 14th 2019Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease and ulcerative colitis, with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).
Infliximab Saves on Short-Term Costs in ASUC, and Biosimilars Could Help
February 12th 2019Acute severe ulcerative colitis (ASUC) can occur in up to 25% of patients with UC. Salvage therapy with infliximab or cyclosporine is standard first-line therapy for patients who do not respond adequately to intravenous corticosteroids, but questions have arisen about the cost-effectiveness of this approach versus early colectomy. A recent study, conducted in a tertiary hospital network in Australia, sought to compare healthcare utilization and costs between patients with ASUC who had early colectomy and those who were treated with infliximab.
Patient Awareness of Biosimilars Impacts Adherence, but Nurse-Led Education Could Help
January 23rd 2019Despite the fact that biosimilars have a longer history in the European Union than in the United States, many European patients still lack awareness of these medicines, and data suggest that a lack of awareness may be keeping patients from adhering to their therapies.
New Research Finds Switching to CT-P13 Is Safe in IBD, and So Is Switching to the Reference
January 14th 2019The body of evidence demonstrating the safety and efficacy of biosimilar infliximab, CT-P13 (Inflectra, Remsima), is growing, particularly in the extrapolated indication of inflammatory bowel disease (IBD). This month saw the publication of 2 new studies that provided reassuring data on CT-P13, one of which focused on switching pediatric patients with IBD to CT-P13, and the second of which explored switching to the reference infliximab from the biosimilar in adults with IBD.
Researchers Report Positive Early Data for SB2 in Treating IBD
January 4th 2019A recent letter, published in Alimentary Pharmacology and Therapeutics, reported on early findings from an ongoing, 18-month, multicenter, observational prospective study conducted among the cohort of the Sicilian Network for Inflammatory Bowel Disease (IBD). According to the authors of the letter, these are the first data on SB2 in treating IBD.
Risk of TB High in Indian Patients With IBD Who Receive Infliximab
December 31st 2018Data on the risk of tuberculosis (TB) reactivation with infliximab therapy in patients with inflammatory bowel disease (IBD) who are from countries where TB is particularly prevalent, such as India, remains limited. A recent study sought to evaluate the rate of tubercular reactivation with infliximab in a cohort of patients with IBD.
Study in Patients With IBD Finds Good Long-Term Efficacy of CT-P13
December 31st 2018Biologic drugs can effectively treat inflammatory bowel disease (IBD), but the cost of these products can be prohibitive. Biosimilars such as CT-P13 (Remsima, Inflectra), an infliximab biosimilar referencing Remicade, have the potential to drive down treatment costs and enhance access to biologics for the patients who need them.
Study: Vedolizumab In the First Line Brings Down IBD Treatment Costs
December 29th 2018Vedolizumab is approved by the FDA for the treatment of moderate to severe Crohn disease or ulcerative colitis, both forms of inflammatory bowel disease (IBD), who have had an inadequate response or loss of response to immunomodulators, tumor necrosis factor inhibitors, or corticosteroid therapy.
French Study Finds CT-P13 Equivalent to Reference Infliximab in CD
December 16th 2018The authors concluded that in their analysis of real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with Crohn disease (CD) who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.
Dose Escalation of Adalimumab Can Overcome Loss of Response in CD
November 19th 2018In many regulatory territories, patients with Crohn disease (CD) who lose response to adalimumab at a dose of 40 mg given every other week may be given an escalation to 40 mg every week. However, in Japan, where adalimumab is typically administered by a healthcare provider rather than by the patient, a study investigated the efficacy, safety, and pharmacokinetics (PK) of adalimumab after a dose escalation to 80 mg every other week as a means to reduce the need for additional patient appointments.
More UK Evidence Documents Successful Switching to Biosimilar Infliximab
November 19th 2018During the 83rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the United Kingdom reported on yet another large, nonmedical switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), this time in the Pennine Acute Hospitals Trust.
Does Biosimilar Infliximab Have a Role After Secondary Loss of Response to Its Reference?
November 15th 2018Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade).
Researchers Present Findings on Adherence Risk Factors, Outcomes of Early Disease Control in IBD
November 12th 2018When treating any disease, adherence is key. Specifically, however, in inflammatory bowel disease (IBD), adhering to biologic therapy is critical in the management of these diseases, as previous research has demonstrated that a medication possession ratio (MPR) of less than 0.86 significantly increases the risk of disease flare.
Existing Data Support the Use of Biosimilars in Pediatric IBD
November 12th 2018Early-onset inflammatory bowel disease (IBD) can have a more aggressive course than later-onset disease, making prompt treatment for children with IBD especially important. Given the high cost of biologics that treat pediatric IBD—adalimumab and infliximab—biosimilars are emerging as an important cost-saving option that can prevent the premature termination of biologic therapy for financial reasons.
Systematic Review Does Not Find Significant Risk Associated With a Single Switch
November 12th 2018As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.
Largest Study to Date in Patients With IBD Finds Switch to CT-P13 Safe and Effective
October 29th 2018While real-world data, such as those derived from the NOR-SWITCH study, have been reassuring about the feasibility of switching patients with inflammatory diseases from reference infliximab (Remicade) to biosimilar CT-P13 (sold as Inflectra and Remsima), some ambiguous data in patients with inflammatory bowel disease (IBD) have raised questions among clinicians about switching in the indications of Crohn disease and ulcerative colitis.
Switching to Biosimilars in the NHS Provides Savings, Presents Unique Challenges
September 26th 2018Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).
Review Urges Better Guidelines for Optimal Management of Patients With Crohn Disease
September 14th 2018Up to 60% of Crohn disease patients taking an anti—tumor necrosis factor (TNF) monoclonal antibody medication eventually stop responding to treatment, but the optimal management of these patients has not been clearly defined.
Study: North American Doctors Use Anti-TNFs in Pediatric IBD Differently From Peers
July 29th 2018“The common initiation in North America of infliximab as monotherapy is concerning, given the now substantial body of evidence…documenting the importance of concomitant [immunomodulators] in reducing the likelihood of secondary loss of responsiveness related to anti-infliximab antibodies," write the researchers.
Study Examines Potential Role of Biologics in Treating Primary Sclerosing Cholangitis
June 30th 2018Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.
Review Addresses the Role of Anti-TNFs in Intestinal Behçet Disease
June 28th 2018Intestinal Behçet disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.