Tagged as: FDA

FDA Releases Internal Workload Study

The Biosimilar User Fee Act (BsUFA) requires FDA to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. On February 24, 2016, the FDA released the Final Results Report of its…

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House Subcommittee on Health Addresses BPCIA Implementation and FDA Biosimilars Guidance

The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…

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FDA Plans to Release Biosimilarity Guidances in 2016

Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity: Considerations in Demonstrating Interchangeability With a Reference Product Labeling for Biosimilar Products Statistical Approaches to Evaluation…

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