May 16th 2024
Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
UK Group Reports on a Successful Switch to Biosimilar Etanercept
August 7th 2019Anti–tumor necrosis factor medicines are one of the costliest drugs for many health systems, and in the United Kingdom, a recent article described how one clinical commissioning group managed the switch of patients on the originator etanercept (Enbrel) to a biosimilar (Benepali) using a fixed-price model.
Systematic Review Underscores the Safety and Efficacy of SB4 in Both Switched and New Patients
August 6th 2019Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.
Study Finds Strong Retention at 4 Years for Patients With AS Treated With CT-P13
August 2nd 2019Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.
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.
Biosimilar Rituximab Appears to Be Safe in Mixed Cryoglobulinemic Vasculitis
July 27th 2019Mixed cryoglobulinemic vasculitis—a rare disorder that is characterized by the presence of abnormal proteins in the blood that become insoluble at low temperatures and restrict blood flow—may be successfully managed with the use of rituximab as a generally well tolerated, glucocorticoid-sparing therapy.
Finnish Study Finds Anti-TNF Agents More Cost-Effective Than Rituximab in RA
July 25th 2019A patient-level simulation model using real-world data from Finland evaluated the cost-effectiveness of abatacept, tocilizumab, and anti–tumor necrosis factor (anti-TNF) therapies as compared with rituximab in patients with rheumatoid arthritis (RA) who received previous treatment with an anti-TNF agent.
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
July 23rd 2019The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.
Recent Reports Explore Drug Survival, Cost Savings in Switches to Biosimilar Etanercept
July 18th 2019Patients with inflammatory diseases in the United States continue to wait for the availability of a biosimilar etanercept, despite the 2016 approval of Erelzi and the 2019 approval of Eticovo. However, in the European context, biosimilar etanercept is already available, and recently presented data demonstrate that, in some countries, use of the biosimilar is high and making an impact on healthcare costs.
Using Value-Based RA Pathway Leads to a Shift to Biosimilars for AHG
July 17th 2019A variety of policy proposals have been put forward to help spur the US uptake of biosimilars, from legislative solutions to regulatory changes, but some providers are taking the matter into their own hands with concerted efforts to bring biosimilars to the clinic.
In a Single-Center Study, Patients With AS Remained in Remission After a Switch to CT-P13
July 14th 2019As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.
Samsung Bioepis Gains EU Label Update for Biosimilar Adalimumab, Imraldi
July 8th 2019Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.
In Treating RA Pain, Could JAK Agents Beat Adalimumab?
July 6th 2019A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.
As Biosimilar Adalimumab Gains Ground in Europe, Ixekizumab Shows Superiority to Humira in PsA
July 2nd 2019Given the head-to-head data from the SPIRIT trial, Humira maker AbbVie may face even further challenges in trying to maintain its sales as newer products like ixekizumab advance in such therapeutic areas as psoriatic arthritis (PsA).
Switching to Biosimilar Rituximab, Truxima, Is Effective and Well Tolerated in Patients With RA
June 25th 2019Recently, researchers reported 72-week results from a phase 3 trial of biosimilar rituximab, CT-P10 (Truxima), in patients with rheumatoid arthritis (RA), in which they concluded that the product was well tolerated in long-term use and that switching from the reference did not yield differences in safety, efficacy, pharmacodynamics, or immunogenicity.
Celltrion Presents More Data Showing Comparable Efficacy, Safety of Subcutaneous CT-P13 to IV Form
June 19th 2019Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).
In the Short Term, Most Patients With RA Remain on a Biosimilar Post Switch
June 16th 2019During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, researchers from the University of Manchester reported on their findings regarding patients with rheumatoid arthritis (RA) involved in the BSRBR-RA study who had switched from reference infliximab or reference etanercept to biosimilars.
Biosimilar Adalimumab, Hulio, Is Safe Long-Term, Causes Less Injection-Site Pain Than Humira
June 14th 2019During this week’s European League Against Rheumatism Annual European Congress of Rheumatology, researchers will present on the long-term safety, immunogenicity, and efficacy of the biosimilar versus the reference in an open-label extension study that involved switching between the biosimilar and the reference.
Real-World Data on SB4 Highlight Biosimilar Etanercept's Efficacy
June 12th 2019During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, multiple teams of researchers will present their findings on real-world evidence of the biosimilar’s efficacy and the feasibility of switching to SB4 from the reference etanercept, Enbrel.
In the Changing Biosimilar Landscape, Canadian Rheumatology Association Updates Its Position
May 30th 2019The Canadian Rheumatology Association (CRA) has issued an update to its position statement on biosimilars. In the document, the CRA says that evidence for the risk/benefit ratio for biosimilars is accruing rapidly, and physicians must demonstrate fiscal responsibility while providing the best care possible to individual patients.
Study Identifies Risk Factors for Infliximab Discontinuation in RA
May 27th 2019A study presented at the recent ISPOR 2019 meeting assessed both the cost associated with treatment with infliximab for patients at US hospitals as well as reasons for discontinuation of therapy during follow-up, and it found that insurance coverage status is one factor that plays a role in discontinuation of this therapy that rose consistently in price over the study period.
Biosimilar Monotherapy Sequence for RA Can Be Considered Cost-Effective, Study Finds
May 21st 2019Rheumatoid arthritis (RA) has a considerable economic burden, and costly biologics, are often restricted to cases in which patients fail to respond adequately to methotrexate or other conventional disease-modifying antirheumatic drugs, which may be difficult for some patients to tolerate.