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Biosimilar Meeting Requests Increase, But FDA Cancels Some For Lack Of Data

 
• By Derrick Gingery

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.

Interest in biosimilars among industry is increasing, but some still don’t seem to understand the requirements of the system FDA is using at the IND stage.

The agency has received 50 requests for initial meetings with potential biosimilar sponsors to talk about development plans and conducted 34

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