Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules
SEOUL - South Korea's FDA is getting ready to release - possibly by the end of May - an initial version of guidelines for approval and registration of biosimilars modeled after European Union rules. The guidelines will wrap up KFDA's year-long drive to set up a regulatory framework for the new breed of follow-on biologics
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Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
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