Can You Still Use Surrogate Markers In A Crowded Drug Class? Sollpura Panel Recommends BMI, Weight Endpoints
Executive Summary
The troubles that Alnara Pharmaceuticals has had with its application for Sollpura (liprotamase) for exocrine pancreatic insufficiency signal the challenges that developers of other drugs in crowded classes may face at FDA.
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As biosimilars loom on the horizon and a number of innovator biologics face the prospect of having to switch production facilities to accommodate growing demand, the advisory committee review of Eli Lilly & Co.'s application for Sollpura illustrates the challenges that a sponsor may face if it disagrees with FDA about a manufacturing issue.
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