New and Emerging Treatment Strategies for Myasthenia Gravis: The Role of the Specialty Pharmacist
1.0 Credit / Neurology
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Improving Treatment Access for Spinal Muscular Atrophy: How Managed Care Strategies Can Ease Clinical and Care...
1.5 Credits / Neurology
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Managed Care Perspectives on the Burden of Food Allergies and Advances in Treatment
1.5 Credits / Allergy, Immunology
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Managing Schizophrenia: Evidence-Based Care and Optimizing Value of New and Emerging Therapies
November 12, 2024 | 1:00 PM & 8:00 PM ET
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PARP Inhibitors for Ovarian Cancer: An Oncology Pharmacist's Guide to the Latest Clinical Advancements
1.0 Credits / Oncology
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Assessing the Treatment Landscape for Multiple Sclerosis to Better Individualize Care
1.5 Credits / Neurology
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Managed Care Pharmacy: A Plan for the Future and How Pharmacists Are Leading the Way
0.5 Credits / General Pharmacy
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Navigating the Evolving Treatment Landscape of Metastatic Renal Cell Carcinoma
2.0 Credits / Nephrology, Oncology
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Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics
October 14th 2024During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.
Pharmacokinetic Modeling Proposes Cost-Effective Dosing for Adalimumab, Etanercept Biosimilars
October 12th 2024A UK cohort study used drug concentration samples from rheumatoid arthritis patients starting the adalimumab biosimilar Amgevita and the etanercept biosimilar Benepali to simulate drug levels under standard and alternate dosing schedules, suggesting that personalized dosing could reduce costs while potentially increasing efficacy.
Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
October 11th 2024Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
October 10th 2024A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.
BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US
October 7th 2024The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD
October 5th 2024A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.
Biosimilar Policy Roundup—September 2024
October 1st 2024In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.
Patient-Reported Outcomes Similar Between Adalimumab-adbm, Reference Product in VOLTAIRE-RA Study
September 28th 2024A summary of research written by Vibeke Strand, MD, clinical professor in division of immunology/rheumatology at Stanford University School of Medicine, gave an overview of patient-reported outcomes (PROs) in the VOLTAIRE-RA trial.
Eye on Pharma: EC Approved Ustekinumab; Zymfentra Expansion; Biosimilar Policy Briefing
September 26th 2024The European Commission (EC) approved Celltrion's ustekinumab biosimilar for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.
AAM Report: Despite Massive Savings, Patient OOP Costs on Biosimilars, Generics Remain High, Part 2
September 24th 2024Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.
BioRationality—The Missing Rationality in Biosimilar Discussions and the Path Forward
September 23rd 2024The article by Sarfaraz K. Niazi, PhD, critiques the irrationality surrounding biosimilars, suggesting that regulatory changes and cost reductions in manufacturing could make biosimilars as affordable as generic drugs.
French Study Finds High Patient Satisfaction With Adalimumab Biosimilar Treatment for IBD
September 21st 2024An observational study assessing patient satisfaction with adalimumab for inflammatory bowel disease (IBD) reported a high level of satisfaction with all adalimumab product, including biosimilars.
AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1
September 18th 2024Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from the Association for Accessible Medicines (AAM).