Biosimilar Meeting Requests Increase, But FDA Cancels Some For Lack Of Data
This article was originally published in The Pink Sheet Daily
Some early meeting requests from potential biosimilar sponsors were not held because they did not include the necessary information for FDA to give development advice.
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The agency changes its rhetoric on the subject, inviting speculation about whether a marketing application has been received.
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.
FDA’s fourth biosimilars-related guidance describes the formal meeting process for sponsors with products in development; the process will require extensive requests and information packages.