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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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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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The Growth of Biosimilars Continues to Create Hope for Lower Drug CostsPerhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
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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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Confusion Persists Around the Interchangeability Designation for BiosimilarsThe legal and common uses of “interchangeability” continue to be conflated.
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Learning the Lingo of Biologics and Biosimilars Is CriticalThe number of FDA-approved biologics has exploded, and biosimilars are making their mark.
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Contributor: What’s Behind the Slow Uptake of Biosimilars in the US?Dan Danielson, RPh, MS, senior director, market access solutions, at PrecisionValue, a market access marketing firm, explains the remaining issues at play slowing down biosimilar uptake in the United States.
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The Inner Workings of the BPCIA Patent DanceThe Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.
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BLA Resubmitted to FDA for On-Body Injector Presentation of Pegfilgrastim-cbqvThe biologics license application (BLA) seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of Neulasta Onpro, has been resubmitted to the FDA for review.
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Dr Ivo Abraham Column: Biosimilars and the Commoditization of TreatmentsIvo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores whether biosimilars should be considered a commodity and if the commodification of medications is sustainable as the market continues to expand.
