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BIOSIMILAR APPROVALS
Authors
Alejandro Menchaca, JD
Latest:
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.
Kristi Rosa
Latest:
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.
University of Arizona R. Ken Coit College of Pharmacy
Latest:
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.
