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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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Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmDTyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.
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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.
