Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Omnitrope Clears FDA: Is the Next Hurdle Congress?

This article was originally published in RPM Report

Executive Summary

The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration's approval of Sandoz' recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.

You may also be interested in...

Another “Biosimilar” Milestone: FDA Tentatively Approves Lilly/BI Copy Of Lantus

It isn’t a 351K pathway drug, but it does set up an interesting comparison for sponsors using the formal biosimilar pathway compared to the 505(b)(2) NDA route.

Preparing for the Arrival of Follow-On Biologics

A handful of follow-on biologics are already offered in European and American markets, but have yet to cause signifi cant brand erosion. Yet despite ongoing regulatory and commercial uncertainties, Big Pharma and small molecule generics companies have been making strategic moves to enter into the biosimilar arena. This article, written by experts from the Campbell Alliance, examines the current movement toward an abbreviated approval pathway for follow-on biologics in the US and assesses the potential impact on current biotechnology products. In addition, the article provides some insight into what commercial and reimbursement decision makers for biotechnology companies should be doing to prepare for the arrival of biosimilars.

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

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


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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