Mylan Head Warns of "Whisper Campaign" Against Biosimilars
November 16th 2017At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.
Research Documents Real-World Experience With Biosimilar Infliximab, Etanercept
November 9th 2017Three presentations at the 2017 American College of Rheumatology’s Annual Meeting in San Diego, California, covered research on the real-world treatment of rheumatology patients with originator infliximab therapy and biosimilar infliximab (CT-P13; Inflectra and Remsima) and etanercept (Benepali) therapy.
New Online Consultation Tool Empowers Patients With Rheumatic Diseases, Study Finds
November 9th 2017Chinese researchers employed a new online consultation tool to improve disease management for patients with rheumatic diseases who travel long distances for a consultation with their rheumatologist and noted significant savings for the patients.
Research Presented on 4 Proposed Etanercept Biosimilars
November 9th 2017Four presentations on Monday at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research comparing reference etanercept to 4 proposed biosimilars: SB4, LBEC0101, CHS-0214, and GP2015.
BI Announces 1-Year Data on Adalimumab Biosimilar, Cyltezo
November 8th 2017At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).
Obese Patients With Rheumatoid Arthritis Less Likely to Achieve Remission
November 8th 2017Research presented at the 2017 American College of Rheumatology Annual Meeting found that patients with rheumatoid arthritis and higher body mass index were less likely to achieve remission and more likely to face higher rates of disability.
4 Studies Address Successes, Failures, and Strategies in Non-Medical Biosimilar Switching
November 8th 2017Today, 4 presentations at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research on switching studies concerning etanercept and infliximab biosimilars.
Biosimilars Present Distinct Challenges in Rheumatology Practice
November 7th 2017In a presentation titled “Biosimilar Medicine: Changing Landscape in Health Care,” given on Monday at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, J. Eugene Huffstutter MD, FACP, FACR, shared practical considerations for using biosimilars in the rheumatology clinic.
Research Focuses on Proposed Adalimumab Biosimilars
November 6th 2017Three presentations at this week’s 2017 American College of Rheumatology Annual Meeting in San Diego, CA, cover research on pharmacokinetic equivalence, safety, and switching of 2 proposed adalimumab biosimilars, GP2017 and CHS-1420.
2 Surveys Highlight Rheumatologists' Knowledge Gaps With Biosimilars
November 6th 2017Two posters presented today at the American College of Rheumatology’s 2017 meeting in San Diego, California, highlight the gaps in US rheumatologists’ knowledge concerning biosimilar therapies, and underscore the importance of greater physician education about biosimilar medicines.
Federal Perspective on the Biosimilar Influence on Drug Costs
September 14th 2017Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.
Industry Regulatory Experts Share Learnings From the Biosimilar Approval Process
September 14th 2017During a panel on the second day of the 2017 AAM Biosimilars Council Conference, held in Washington DC, regulatory leaders from Pfizer and Sandoz shared their experiences with the development of their biosimilar products: epoetin alfa (Epogen) and etanercept (Erelzi), respectively.
A European Perspective on Biosimilars
September 13th 2017At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”
Advocates Emphasize Need for Patient Cost Savings From Biosimilars
September 13th 2017On Tuesday, leaders of patient advocacy groups presenting at the 2017 AAM Biosimilars Council Conference had a clear message for industry: biosimilar uptake will only happen in earnest when patients begin to see savings on their out-of-pocket treatment costs.
AAM Executive: 1.2 Million Will Gain Treatment Access Because of Biosimilars
September 12th 2017Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.
Research Highlights Filgrastim and Pegfilgrastim Biosimilars
September 11th 2017Three posters presented on September 10, 2017, at the European Society for Medical Oncology (ESMO) 2017 meeting in Madrid, Spain, covered research on 2 proposed pegfilgrastim biosimilars and evaluated the use of filgrastim in oncology practice.
Exhibit Caution When Interpreting PFS, OS Data in Biosimilarity Studies
September 9th 2017Oncology trials often report on progression-free survival or overall survival, but the authors of an analysis presented during a poster session today at the European Society of Medical Oncology (ESMO) Congress argue that such endpoints are less sensitive then short-term overall response rate.
Biosimilar Insulin Glargine Shows Pharmacokinetic and Pharmacodynamic Equivalence to the Originator
June 15th 2017The study pesented at the American Diabetes Association 77th Scientific Sessions compared Mylan/Biocon’s MYL-1501D, a proposed biosimilar to Sanofi-Aventis’ insulin glargine, with the reference product.
CT-P6, a Trastuzumab Biosimilar, Shares the Safety and Efficacy Profile of Its Reference
June 8th 2017Research presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) shows that CT-P6, a proposed trastuzumab biosimilar, is safe and effective as a neoadjuvant treatment in HER2–positive early breast cancer.