April 29th 2024
The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Cost May Drive Medicare Patients to Delay or Forego Treatment for Blood Cancer, Report Suggests
October 24th 2019A new research report from Milliman, commissioned by the Leukemia and Lymphoma Society (LLS), found that fewer than half of patients with blood cancer received treatment within 3 months of diagnosis, and LLS says that costs may be keeping patients from getting care.
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.
"Not So Different": Are We Ready for Biosimilar Rituximab in the United States?
October 20th 2019It’s widely expected that the United States will see launches of one or both of the FDA-approved rituximab biosimilars, Ruxience and Truxima, in the coming months, but just how ready is the United States to bring these products to the clinic, especially given the fact that subcutaneously administered reference rituximab has taken on such a key place in clinical practice, and given the fact that both biosimilars have so-called “skinny labels” because of issues related to intellectual property and exclusivities?
Oncologist Experience With Rituximab Factors Into Early Discontinuation Rate
October 15th 2019The less experience an oncologist has with administering rituximab, the more likely a Medicare beneficiary with non-Hodgkin lymphoma is to discontinue treatment, according to a new study. In addition, early rituximab discontinuation was associated with inferior lymphoma-specific and overall survival.
ISOPP Releases Position on Biosimilars, Voices Opposition to Treating Biosimilars as Interchangeable
October 11th 2019The International Society of Oncology Pharmacy Practitioners (ISOPP), which convened in London, United Kingdom, this week for its 18th international symposium on oncology pharmacy practice, has issued a new global position statement on biosimilars in therapeutic and supportive oncology.
Samsung Bioepis' Etanercept Biosimilar Performs in Real-World Treatment of Psoriasis
October 9th 2019In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.
Pediatric Patients and Their Families Report Unique Concerns When It Comes to Biosimilar Switching
October 7th 2019According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns were related to device type, the presence of a citrate, or the color of the product.
Novartis to Seek a Fourth Indication for Secukinumab
October 2nd 2019Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.
COA Issues Policy Statement on Step Therapy in Cancer Care
October 1st 2019Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).
ESMO 2019 Features Data on Biosimilar Pegfilgrastim and Filgrastim
September 30th 2019During the European Society for Medical Oncology (ESMO) Congress 2019, researchers provided a detailed look at a 3-treatment, 6-sequence crossover study for a pegfilgrastim biosimilar, and a separate team presented on the use of biosimilar filgrastim in patients who are being given chemotherapy regimens that involve a rest period of up to 14 days.
Biogen Director Shares Lessons Learned From EU Biosimilar Commercialization
September 25th 2019During the opening day of the SMi 10th Annual Biosimilars Conference, held September 25-26 in London, United Kingdom, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, shared his experience with anti–tumor necrosis factor biosimilars in general, and with biosimilar adalimumab in particular, in the EU marketplace.
Celltrion Receives Positive CHMP Opinion for Subcutaneous Infliximab Biosimilar, CT-P13
September 23rd 2019During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.
Studies Report on Efforts to Optimize Rituximab in MS, NMOSD
September 21st 2019While rituximab does not carry indications for the treatment of multiple sclerosis (MS) or aquaporin-4-positive (AQP4) neuromyelitis optica spectrum disorder (NMOSD), the CD20-depleting therapy and its biosimilars are commonly used off-label, as the therapy has been demonstrated to be effective in reducing relapses in MS as well as in reducing the frequency and severity of attacks in NMOSD.
Vial Sharing for Bevacizumab in Treating Eye Disorders Reduces Costs, Increases Access
September 18th 2019Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.
Patients With Rheumatic Diseases Face Substantial Hurdles in Accessing Treatment, ACR Says
September 16th 2019While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.
With a Biosimilar on the Horizon, New Data Give an Important Look at Natalizumab in MS
September 11th 2019Just last week, Sandoz indicated that it will commercialize a biosimilar of the multiple sclerosis (MS) drug natalizumab (Tysabri). This week, during the 35th meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers will present data that help contextualize natalizumab’s place in the treatment paradigm for MS.
Across 36 RCTs, No Difference Between Reference, Biosimilar Anti-TNFs in RA Joint Destruction
September 9th 2019For patients with rheumatoid arthritis (RA), avoiding damage to cartilage and bone in the joints is a key consideration for treatment. While anti–tumor necrosis factor (anti-TNF) therapies are used to treat RA and reduce joint destruction, the available anti-TNF agents, both originator and biosimilar, have not been directly compared with one another or with placebo in terms of their impacts on joint damage. A new study, published last week, attempted to address that gap in the literature by conducting a meta-analysis of randomized controlled trials (RCTs).
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.