Search Results: Regulatory Guidances

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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NHS Releases Biosimilars Guidance, Prohibits Automatic Substitution

On September 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing…

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