July 24th 2024
Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Subcutaneous Formulation of Celltrion's Biosimilar Infliximab Authorized by European Commission
November 26th 2019Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.
More Data Needed on Using Biologics in Children, Review Says
November 18th 2019A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).
After Public Drug Coverage for Infliximab, Adalimumab, Surgeries and ED Visits for CD Fell
October 29th 2019Between 2003 to 2014, patients in Ontario, Canada, received public drug benefits for infliximab or adalimumab at a combined rate of 2.2% in 2003, rising to 18.8% of eligible patients by 2014. During that period, the prevalence of Crohn‐related hospitalizations fell 32.4%.
ACG Case Studies Report on AEs, and Their Resolution, With Biosimilar Infliximab
October 29th 2019This week, clinicians gathered in San Antonio, Texas, for the American College of Gastroenterology (ACG)’s 2019 meeting, where a number of presentations focused on the treatment of inflammatory bowel disease. During the congress, 2 studies presented addressed adverse events (AEs) associated with—one of which was resolved by—the use of biosimilar infliximab, CT-P13 (Inflectra).
Canadian Gastroenterology Groups Issue Joint Position That Takes Aim at Nonmedical Switching
October 25th 2019The Canadian Association of Gastroenterology and Crohn’s and Colitis Canada this week announced a joint statement on biosimilars in the treatment of inflammatory bowel disease (IBD). The paper, which is slated to appear in the Journal of the Canadian Association of Gastroenterology, recommends that patients stable on biologic treatment should not be subject to nonmedical switching, and recommends against automatic substitution of biosimilars for their references.
Pooled Analysis Underscores Safety of Biosimilar Infliximab, CT-P13, in Patients With IBD
October 24th 2019During the United European Gastroenterology Week 2019, held October 29-23 in Barcelona, Spain, researchers from Celltrion presented pooled data from 3 postmarketing studies of CT-P13 in patients with inflammatory bowel disease (IBD) that underscore the safety of the biosimilar.
At UEG 2019, Data Shed Light on Monitoring of Biosimilar Adalimumab, Imraldi, in IBD
October 22nd 2019Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.
In IBD, Celltrion's Subcutaneous Infliximab Biosimilar Proves Noninferior to Intravenous Option
October 21st 2019During the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers presented results of a phase 1 pivotal study of a subcutaneously administered formulation of biosimilar infliximab, CT-P13 (Remsima, Inflectra), in patients with inflammatory bowel disease (IBD).
Two Studies Report Results of Vedolizumab, Adalimumab, Ustekinumab for Ulcerative Colitis
September 26th 2019A pair of studies appearing in The New England Journal of Medicine report on 2 separate studies of biologics in patients with moderate-to-severe ulcerative colitis: One study confirms top-line results seen earlier this year in a head-to-head study of vedolizumab and adalimumab, and the other reports on the results of a single intravenous infusion of ustekinumab followed by subcutaneous maintenance injections.
AHIP Report Cites Reference Biologics as Examples of Orphan Drug Gaming
September 17th 2019While acknowledging the role that the Orphan Drug Act had in incentivizing drug companies to develop treatments for small populations suffering from rare diseases, America’s Health Insurance Plans (AHIP) says pharmaceutical companies are using orphan drug status to create blockbuster drugs that are then used to treat other common medical conditions.
ICER to Assess Treatments for Ulcerative Colitis, Including Biosimilar Infliximab
September 14th 2019The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.
Paper Suggests That Oral Delivery of Biosimilar Infliximab, CT-P13, May Be Feasible
September 11th 2019A paper published in Pharmaceutics describes development and validation of a production process for 5 mg tablets of infliximab, using biosimilar CT-P13 (Remsima, Inflectra), for the treatment of inflammatory bowel disease.
Ustekinumab Gets Expanded European Label With New Ulcerative Colitis Indication
September 8th 2019Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis. Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.
Japanese Study: CT-P13 Is Interchangeable With Remicade in Real-World IBD Treatment
August 27th 2019A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.
Point-of-Care Test Nearly Identical to ELISA at Detecting ADAs to Biosimilar Infliximab, SB2
August 15th 2019A recent study of a rapid point-of-care (POC) test shows that it is virtually identical at detecting antidrug antibodies (ADAs) to a biosimilar infliximab, SB2 (Renflexis, Flixabi), as a standard enzyme-linked immunosorbent assay (ELISA) and is suitable for therapeutic drug monitoring of any infliximab product.
Paper Proposes Methodology to "Protect Health Systems" That Use Biosimilars
August 7th 2019A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing.
Celltrion Begins Recruiting US Patients for Phase 3 Study of Subcutaneous CT-P13
August 1st 2019Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.
In IBD, Switching to Biosimilar Infliximab Remains Safe and Effective at 2 Years, Study Finds
July 11th 2019The study, conducted at a hospital in Spain from 2015 to 2017, included all 100 patients who were switched to the biosimilar from the reference infliximab when the hospital transitioned to using the lower-cost product.
In Switching to Biosimilar Infliximab in IBD, Rapid Infusion Protocols Are Safe
July 2nd 2019As more centers begin to switch patients from reference infliximab to biosimilar options, patients who have benefitted from rapid infusions of the reference product may want to continue to receive time-saving infusions that reduce the burden of lengthy visits to infusion centers.
More Data Underscore the Importance of Educating Patients as Part of a Biosimilar Switch in IBD
July 1st 2019In a study conducted from 2017 to 2018 among all of the infliximab-treated patients with inflammatory bowel disease (IBD) in a single center, patients who were in clinical remission were invited to complete a questionnaire to assess their biosimilar knowledge and acceptance of a switch.
Infliximab Did Not Result in Lower Rate of Hospitalizations, Surgeries in Canadian Study
June 13th 2019The introduction of infliximab for the treatment of inflammatory bowel diseases (IBD) did not result in lower population rates of hospitalizations or intestinal surgeries among patients living with IBD in Ontario, Canada, according to a study published Thursday.