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.
Real-World Data Reaffirm Biosimilar Filgrastim's Safety and Efficacy
June 19th 2019During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.
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.
Systematic Literature Review Calls Economic Impact of Switching to Biosimilars "Uncertain"
June 10th 2019“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.
MS Experts in Latin America Publish Recommendations for Biosimilar Policies
June 3rd 2019With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.
Bevacizumab Could Help Patients With NSCLC Who Cannot Receive PD-1 Inhibitors
June 2nd 2019“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.
Real-World Data Suggest CT-P13 Carries Lower Risk of Infection Than Remicade
May 29th 2019Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.
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.
Data Support Advanced Preparation of Reconstituted and Diluted Biosimilar Trastuzumab, SB3
May 21st 2019Extended stability data for the reference Herceptin have been published, supporting advanced preparation and dose banding. Given stability data for SB3 are limited, a new study sought to assess the extended physiochemical stability and bioactivity of the biosimilar and to evaluate the advanced preparation of the reconstituted and diluted product.
Study Highlights Importance of Limiting Glucocorticoid Use in Biologic-Treated Patients With RA
May 21st 2019Patients with rheumatoid arthritis (RA) have similar rates of infection after total knee or hip replacement no matter which biologic they take, but those using glucocorticoids, even moderate doses, appear to have an increased risk of postoperative infections, according to a study published today.
Health Plan Restrictions Likely to Have an Impact on Biosimilars, Orphan Drugs
May 20th 2019Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.
FDA Approves New Aflibercept Indication Ahead of Competition
May 17th 2019The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.
Study Finds Fewer Severe Infections With Newer Psoriasis Therapies Versus Methotrexate
May 10th 2019Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.
Eculizumab Shows Positives Results in Cutting Relapses of Neuromyelitis Optica Spectrum Disorder
May 9th 2019A phase 3 trial of eculizumab found the drug reduced the frequency of relapse neuromyelitis optica spectrum disorder (NMOSD), an autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord.
As Evidence Base for Biosimilars Grows, So Too Will Confidence in Switching, Review Says
May 7th 2019Despite potential benefits of biosimilar adoption in terms of both patient access and healthcare system sustainability, and despite ongoing efforts at patient and provider education on biosimilars, stakeholders may continue to have concerns about perceived risks with switching. A new review of the available literature on switching—from randomized controlled trials and real-world evidence—sought to address those concerns, and said that additional education and ongoing real-world evidence collection will be necessary to increasing stakeholder comfort with these agents.
UK Researchers Hope Adalimumab Will Prove to be Cost Effective in Dupuytren Disease
May 4th 2019Dupuytren disease (DD), a common, fibroproliferative condition of the hand that can cause contracture of the fingers, currently has no approved treatment for its early stages, and surgical intervention is often required as the disease progresses.
Biosimilar Infliximab, Zessly, Maintains Safety and Efficacy Under Extended In-Use Conditions
May 3rd 2019The authors concluded that the physiochemical and biological analyses demonstrated that the biosimilar is not affected by reconstitution, dilution, and extended storage in infusion bags. These findings, they write, provide added reassurance to healthcare providers that the biosimilar is safe and effective under extended in-use conditions.
ACR and AF Release Guidelines for 2 Subtypes of Juvenile Idiopathic Arthritis
May 2nd 2019The American College of Rheumatology (ACR) and the Arthritis Foundation (AF) released guidelines for treating 2 subtypes of juvenile idiopathic arthritis (JIA), which affects nearly 300,000 children in the United States. One guideline discusses therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis; the other focuses on the screening, monitoring, and treatment of JIA with associated uveitis. The second guideline focuses on uveitis, which can be a chronic or acute disease.
Eculizumab May Allow Patients With MG to Reduce Immunosuppressive Therapy
May 2nd 2019The researchers wrote that that a numerically larger proportion of patients with myasthenia gravis (MG) stopped or reduced their doses of immunosuppressive therapies than started or increased, and that symptom improvement or worsening were the main reasons for changes to concomitant therapy.
Study Finds That Disability in RA Begins 1 to 2 Years Before Diagnosis
May 1st 2019Functional disabilities start to appear in patients with rheumatoid arthritis (RA) 1 to 2 years before diagnosis, signaling that earlier diagnosis and more aggressive treatment may lessen the burden of disease, according to a study released today.
Switching Between Biosimilar Infliximab Products Not Associated With AEs or Change in PASI
April 26th 2019This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases. During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.