Tagged as: FDA

UPDATED: FDA Requesting Comments on Biomarker List

FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics from October 2007 to December…

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FDA Announces Biosimilar User Fee Rates for FY 2017

The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year: FY17 BsUFA Fees Biological Product Development Initial $203,810 Annual $203,810 Application w/Clinical Data $2,038,100 w/o Clinical Data $1,019,050 Supplement w/Clinical Data $1,019,050 Product $97,750 Establishment $512,200 Reactivation $407,620 The biosimilar user fees for a given fiscal year…

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FDA Offers Perspectives on Enhancements to the Application Review Model

In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…

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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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