Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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.

Advertisement

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register