Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.
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Asked during Senate hearing whether the 351(k) pathway would be repealed along with the rest of the ACA under a pending lawsuit, the outgoing commissioner acknowledged that it would, but said he hoped Congress would create it again.
Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.
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