Tagged as: FDA

FDA Releases Five-Year Plans for User Fee Programs

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans “communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017 (BsUFA II), the Generic Drug User…

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Commissioner Gottlieb Addresses Biosimilars at Conference

At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars.  His comments largely tracked a statement that he made in early March. Gottlieb again criticized arrangements between distributors, pharmacy benefit managers, and health plans, which he views as restricting market access. …

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Trastuzumab Biosimilar Demonstrates Equivalence

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…

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FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”  The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in…

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