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.
HTA Frameworks for RA Therapies Need Improvement, Researchers Say
May 13th 2019Cost-effectiveness models for the treatment of rheumatoid arthritis (RA) first emerged in the early 2000s when highly effective but also high-cost biologic therapies began to reach patients. However, these health technology assessment (HTA) models need improvement, a recent paper says.
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.
Eye on Pharma: Fresenius Kabi Launches Biosimilar Adalimumab, Idacio
May 6th 2019Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.
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.
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.
FDA Approves Samsung Bioepis' Etanercept Biosimilar, Eticovo
April 26th 2019The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.
PBM Says Its Biosimilars Strategy Led to 86% Use of Biosimilar Infliximab
April 17th 2019Magellan Rx Management, a pharmacy benefit manager (PBM), said today that its biosimilar management program has resulted in strong biosimilar uptake and significant drug cost savings for health plan organizations during its first year.
Asian Researchers Report Success With Biosimilars in the Rheumatology Clinic
April 10th 2019During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.
Researchers Present Real-World Data on Biosimilar Infliximab Agents at APLAR-ARA
April 8th 2019This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.
Study Reports Long-Term Similarity Between ABP 501 and Humira in Patients With RA
April 7th 2019The study is an open-label extension of a phase 3 trial that included 68 weeks of treatment with the biosimilar adalimumab, Amjevita, followed by an assessment visit at week 70 and an end-of-study visit at week 72.
Golimumab Could Save on RA Costs Versus Biosimilar Infliximab, Study Suggests
April 6th 2019Intravenous golimumab and infliximab are both widely used in the treatment of rheumatoid arthritis (RA) in the United States, though these anti–tumor necrosis factor agents have markedly different dosing recommendations; patients who receive golimumab may receive 7 infusions during year 1, while patients who receive infliximab may receive between 8 and 14 infusions during year 1.
ACR Issues Step Therapy, Drug Pricing Position Statements
April 3rd 2019As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.
Fresenius Kabi Gains European Authorization to Market Adalimumab Biosimilar, Idacio
April 3rd 2019Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.
Reducing the Dose of Anti-TNF Agents Appears Feasible in Spondyloarthritis
March 23rd 2019Recently, a study sought to determine whether dose reductions of anti–tumor necrosis factor (anti-TNF) therapies are possible for long-term treatment of spondyloarthritis, and found that a reduced dose is noninferior to a full dose in patients in sustained clinical remission.
Cellular Response to Infliximab May Be Linked With ADA Development
March 20th 2019Like all biologics, infliximab has the potential for immunogenicity, and the development of antidrug antibodies (ADAs) can lead to loss of response or hypersensitivity reactions. A newly published paper sought to evaluate the development of a cellular response to infliximab and whether such a response could predict ADA development.
Most Patients With AS Stop Their First Anti-TNF Therapy by Year 2, Study Finds
March 14th 2019Recently, a new study sought to examine treatment patterns in US patients new to anti–tumor necrosis factor (anti-TNF) therapy, and it found that a majority of patients, particularly women, do not remain on their first anti-TNF after 2 years.
Are Concerns About JAK Inhibitors Good News for Anti-TNF Biosimilars?
March 2nd 2019In February, the FDA issued a drug safety communication on tofacitinib (Xeljanz), an oral, small-molecule Janus kinase (JAK) inhibitor. According to the FDA communication, a clinical trial in patients with rheumatoid arthritis who were taking an as-yet unapproved 10-mg dose of tofacitinib twice each day found an increased risk of blood clots and death.
Ahead of US Biosimilar Competition for Humira, FDA to Give AbbVie's Upadacitinib Priority Review
February 20th 2019AbbVie has announced that the FDA has accepted for priority review its New Drug Application for upadacitinib for the treatment of rheumatoid arthritis (RA). Upadacitinib is a proposed once-daily, small-molecule, oral Janus kinase inhibitor that, if approved, could be an alternative to therapy with such injectable biologics as AbbVie’s flagship RA treatment, adalimumab (Humira), which will face biosimilar competition in the United States by 2023.
New Research Highlights the Role of Biosimilar Etanercept in Treating Ankylosing Spondylitis
February 13th 2019While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).
No Safety Risks Found in a Switch From Reference Rituximab to GP2013
February 8th 2019GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.