May 4th 2024
A review article summarized the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Lessons Learned From Nonmedical Switching
October 16th 2018As more biosimilars are poised to become available to US patients, American rheumatologists are looking to their European counterparts for lessons learned from nonmedical switches from reference products to biosimilars. During the American College of Rheumatology (ACR) Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, several research teams will present on nonmedical switching in the European context.
Review Finds Better Efficacy of Biologics in Trials Without Placebo
October 15th 2018A review was recently conducted among 2 different types of randomized clinical trials in the treatment of rheumatoid arthritis (RA): those comparing reference biologics’ efficacy versus placebo, and those comparing reference biologics’ efficacy versus biosimilars.
European Analysis Finds Infliximab to Be Most Cost-Effective Biologic for RA
October 11th 2018The paper reports findings from a study that used retrospective data from a single center in Poland from 2009 to 2014. Records from a total of 104 patients, each of whom received infliximab, etanercept, or adalimumab under the National Health Fund, were assessed.
Researchers Present on Making AS Treatment More Affordable and More Effective
September 20th 2018Treating ankylosing spondylitis (AS) is costly, even in high-income nations. In lower-income countries, patients may face serious challenges in accessing high-cost drugs, like anti–tumor necrosis factor agents, even when biosimilars are available.
Effective Switches to Biosimilars Feature in APLAR Research
September 19th 2018During the 20th Asia Pacific League of Associations for Rheumatology (APLAR) Congress, held September 6 to 9 in Kaohsiung, Taiwan, researchers presented on real-world experience with switching to biosimilars in treating rheumatic diseases.
Celltrion Asks NHS to Start Biologics Earlier in Patients With RA
September 5th 2018Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.
Celltrion Completes Phase 3 Trial for Subcutaneous Inflectra
September 4th 2018Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.
Review Suggests That Rheumatologists, Patients Need More Data on Switching to Etanercept Biosimilars
September 2nd 2018Regulators licensed the 3 etanercept biosimilars discussed for all of the indications of the reference drug on the basis of the extrapolation of indications, a practice that the authors say rheumatologists may find “anomalous and a source of debate.”
Australia's PBAC Recommends 2 Adalimumab Biosimilars for Pharmacy-Level Substitution
August 24th 2018Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that 2 adalimumab biosimilars be treated as equivalent to the reference adalimumab, Humira, and be subject to substitution at the pharmacy level.
Survey Finds Patient, Nurse Preference for Biosimilar Etanercept's Autoinjector
August 22nd 2018Because patients with rheumatoid arthritis may have compromised manual dexterity, they may have challenges with self-administering their biologic therapies. In the case of etanercept, which is typically administered once per week, device design that prioritizes ease of use can help improve patient adherence to treatment regimens.
A Switch to Biosimilar Etanercept Yields Mixed Results In Two UK Hospital Systems
August 21st 2018The advent of biosimilar etanercept, Benepali, in the United Kingdom has provided a significant opportunity for cost savings, given the biosimilar’s lower price than the reference Enbrel. As such, hospitals have been undertaking nonmedical switches to the biosimilar in order to benefit from these savings. During the British Society for Rheumatology 2018 Annual Conference, held in May in Liverpool, United Kingdom, investigators reported on the results of these switches, both on the financial wellbeing of the health system and on patients.
European Study: All Biologics Improve Quality of Life in RA, But Rituximab Is Cost-Effective
August 20th 2018The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.
Treating RA With Infliximab, Adalimumab, or Golimumab May Allow for Later Biologic-Free Remission
August 16th 2018In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.
Study: Switching to SB5 From Humira Is Safe and Well Tolerated at 1 Year
August 15th 2018Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events.
Celltrion Announces Simultaneous Phase 1, Phase 3 Trials for Adalimumab Biosimilar
August 8th 2018Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.
Ixifi Has Similar Efficacy to Remicade in RA, With or Without Dose Escalation
August 6th 2018Pfizer’s Ixifi, a biosimilar infliximab product that was approved for all indications of its reference in the United States in December 2017, received FDA clearance with a data package that included findings from a phase 3, randomized, double-blind, active-controlled, multinational study comparing the biosimilar with the reference infliximab in combination with methotrexate in patients with rheumatoid arthritis (RA). The data were presented in an abstract at the American College of Rheumatology’s annual meeting in 2017, and the results for the initial 30-week treatment period have now been published in Arthritis Research and Therapy.
Two Trials of Low-Dose Rituximab Have Implications for Biosimilarity Testing
August 1st 2018The researchers hypothesized that currently used doses of rituximab, of 375 mg/m2 or greater, significantly exceed the half-maximal effective dose of rituximab, at which differences between a biosimilar and the reference would be most likely to be found.
Study: Adalimumab Monotherapy Provides Benefits Up to 3 Years in RA
July 30th 2018While data are becoming more numerous on the feasibility of withdrawing a biologic from a patient who has reached low disease activity (LDA) on combination therapy, data concerning the ability to maintain a treatment target on biologic monotherapy are fewer. A new, post-hoc study reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with RA for up to 3 years in more than half of patients who reached LDA after combination therapy.
On-Demand, Low-Dose Rituximab Proves Effective in Treating RA
July 24th 2018Rituximab, primarily used as a second-line biologic therapy, was used in a cost-saving and adverse-event reducing on-demand schedule in 94.6% of patients; these patients were assessed for signs of relapse and the need for another rituximab infusion at their regularly scheduled visits, and they also had the option of contacting a healthcare provider by phone if they felt that they were relapsing.
AbbVie Settles With a Third Biosimilar Developer Over Humira
July 17th 2018Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.
Switching From Reference Adalimumab to Biosimilar ABP 501 Does Not Cause Immunogenicity
July 13th 2018Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.