Scrip is part 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


2011 Scrip 100: Biosimilars - US to lag behind Europe for years?

This article was originally published in Scrip

Executive Summary

With no formal guidance in place, what can the world expect as the US FDA puts together a regulatory framework for biosimilars? Developers are not waiting for an FOB pathway to take shape, and some have vowed to use the existing BLA route at least in the near future, while others are taking a wait-and-see attitude as they conduct early trials and talk to the FDA. Nancy Faigen reports.


Related Companies




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts