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US FDA's Biosimilar Advisory Committee Policy Evolves

 
• By Derrick Gingery

If first-in-class biosimilar doesn't raise new scientific issues, it may not need advisory committee meeting, FDA's Christl says in interview with the Pink Sheet, suggesting a case-by-case approach going forward.

Identical twins

As the number of biosimilars approved by the US FDA ticks steadily upward, applications in new product classes may not need advisory committee reviews if the relevant issues already have been discussed in a prior public forum. However, that doesn't necessarily mean sponsors are completely in the clear even once a biosimilar is approved in any given class. A biosimilar seeking to enter an already populated market with data different from its competitors still may require input from the agency's outside counselors.

FDA never formally committed to holding advisory committee meetings for all new biosimilar product classes, but had been following that pattern – until June 4, when the agency approved

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