Pink Sheet is part of the Informa 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


Flubbing the FOBs Opportunity: Follow-on Biologics Winners & Losers

This article was originally published in RPM Report

Executive Summary

An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?

Related Content

In Brave New World of Follow-On Biologics, Can't We Do Better Than 1984?
European Biosimilars' Market Performance Mirrors US Legislative Progress: Slow but Steady
Prioritizing Health Care: Reform Gains Early Momentum
Roche/Genentech: A Defensive Play On Follow-on Biologics
Orphaning Biotech? The Impact of Biosimilars on Biotech Investment
Follow-On Biologics Legislation Could Reach Senate Floor By Year End
FDA Gets Practical On Follow-On Biologics As Pathway Remains Theoretical
Betting Generic: Part D, Patents and Proteins Drive Investment Surge
Omnitrope Clears FDA: Is the Next Hurdle Congress?
Biogenerics Are Coming and They're Not the Generics We Know


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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