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Drug makers butt heads on US FDA's proposed biosimilars guidances

This article was originally published in Scrip

Executive Summary

There were few inside the biopharmaceutical industry that didn't have something to say this week about the US FDA's proposed guidance documents intended to help makers of biosimilars understand the agency's expectations about developing the products and how to interact with regulators through the approval process – with even the government of the Republic of Korea chiming in, although its submitted comments contained more inquiries than recommendations.

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