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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co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action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.
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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.
