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Lilly's Solpura Advisory Committee Could Hinge On Manufacturing Issues

This article was originally published in The Pink Sheet Daily

Executive Summary

Alnara, a Lilly subsidiary, says that its exocrine pancreatic insufficiency treatment is supported by two adequate and well-controlled trials, but FDA says that the product has changed so much that only one of them is relevant - and that one doesn't show strong enough efficacy.

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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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