What does FOB stand for?

2 HR 1548 requires that a follow-on biologic applicant demonstrate biosimilarity "based upon data derived from (I) analytical studies that demonstrate that the biological product is highly similar to the reference product .

Currently, the United States does not have a streamlined approval pathway for copies of patented biotech drugs, made from living cells, also known as follow-on biologics or biosimilars.

Recent Company Highlights -- Follow-on Biologics Program -- Received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency to initiate a Phase I clinical study for the company's second follow-on biologic ("FOB") product candidate, INS-20.

We would be happy to support follow-on biologics legislation as long as that legislation is consistent with some very critical principles: first and foremost of course is safety," Greenwood said.

The last three-and-a-half years also saw the approval of the follow-on biologics in Europe, Australia and the US.

Key Topics Covered: * Executive Summary * Aggressive First Steps by the 111th Congress * American Recovery and Reinvestment Act of 2009 * Importation of Drugs * Authorized Generics and Pay-for-Delay Deals * Biosimilars: Follow-On Biologics * Patent Reform Act of 2009 * All Eyes Turn to Healthcare Reform * Outlook * Expert Commentaries * Tables * Figures For more information visit http://www.

Follow-on Biologics in Canada: A Look at the New Draft Guidelines, Update, Issue 3, (May/June 2008), 43–45.

We would be happy to support follow-on biologics legislation as long as that legislation is consistent with some very critical principles: first and foremost of course is safety," Greenwood said.