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Biosimilar Interchangeability and Substitution in the US: What Comes Next?Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.
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Legal Opinion: BPCIA Is Likely to Survive Latest ACA ChallengeIntellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
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Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar InspectionsJulie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.
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Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.
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Opinion: How Will Semglee Interchangeable Insulin Affect Access and Affordability?The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains.
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Biosimilar Interchangeability and Substitution in the US: What Comes Next?Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.
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The Next Frontier: Oncology Biosimilars in 2025 and BeyondThe US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.
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Opinion: The Legal and Regulatory Year in ReviewIntellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.
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Biosimilar Interchangeability and Substitution in the US: What Comes Next?Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.
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What We Learned About Biologics on Summer VacationIntellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.
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Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.
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Opinion: Biosimilars Offer Savings and Access for US PatientsIn this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
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The Banking of Biosimilars: Insights From a Leading Health EconomistBiosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
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Contributor: No Good Deed Goes Unpunished—How PBM Mandates Increase Practice VariabilityJeff Patton, MD, CEO and board member at OneOncology, dived into the controversial role that pharmacy benefit managers (PBMs) play in formulary decision-making and how PBMs impact biosimilar utilization.
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Budget Impact Analysis of Biosimilar Natalizumab in the USProjected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
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What We Learned About Biologics on Summer VacationIntellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.
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Enhancing Biosimilar Adoption in Value-Based Oncology CareTravis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.
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Integrating Biosimilars Into Retina and Neurology Practices Requires Careful PlanningSuccessfully integrating biosimilars into practices requires careful planning and execution, as they impact virtually all aspects of a practice.
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Budget Impact Analysis of Biosimilar Natalizumab in the USProjected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
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Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and BioparallelsIn his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.
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As Biosimilar Substitutions Become More Common, Education and Patient Counseling Are ParamountPharmacists play an essential role in counseling patients on biosimilar substitution protocols and following state regulations regarding interchangeable medications.
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Resources for Patients and Providers on Adalimumab BiosimilarsExpert providers in inflammatory diseases provide additional resources on biosimilars and adalimumab biosimilar for patients and providers.
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Opinion: Biosimilars Offer Savings and Access for US PatientsIn this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
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Biosimilars and Employers: Strategies for SuccessThe author, who is CEO of Pontchartrain Cancer Center, discusses how biosimilars can be part of a strategy for delivering high-quality care while achieving savings.
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CVS Caremark Switches Up Biosimilar Coverage in 2024As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.
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Opinion: Purple Book Patent Listings Are Only a First StepIntellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.
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Confusion Persists Around the Interchangeability Designation for BiosimilarsThe legal and common uses of “interchangeability” continue to be conflated.
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All Things Biosimilars: How Streamlined CES Rules Could Shift the MarketIn this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.
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Confusion Persists Around the Interchangeability Designation for BiosimilarsThe legal and common uses of “interchangeability” continue to be conflated.
