The Burrill Report


The U.S. Food and Drug Administration's approach to reviewing biosimilars will take the form of a two-step process that will be further detailed in a series of agency guidance documents, the first of which will be published at least by year's end, according to a senior FDA official.

“Companies first will submit analytic data showing how similar their compounds are to an FDA-approved innovator version. The agency then will determine on a case-by-case basis how much animal and clinical data are required for approval,” Rachel Behrman, Associate Director for Medical Policy in the Center for Drug Evaluation and Research said during an interview on BioCentury This Week.

Behrman's comments lend insight into the closely-watched process by which the FDA is working to interpret how to implement The Biologics Price Competition and Innovation Act of 2009, a provision of the Affordable Care Act that creates an abbreviated approval pathway for biological products that are demonstrated to be highly similar to, or interchangeable with, an FDA-licensed biological products.

Starting with an assumption that approved biologics are already safe and effective, Behrman said that the agency will be looking for data establishing that biosimilars submitted for approval have the same effect in patients without illustrating clinically meaningful differences.

Once biosimilarity is established, companies could then pursue a second step of review to establish interchangeability, a designation that would allow for the automatic substitution of a biosimilar in place of an already approved biologic.

At least one part of the approval process with some predictability is that companies seeking the approval of biosimilars will have to pay some sort of fees to support the reviews, whatever form the process takes. Though yet to be established, the FDA put out a call May 4 soliciting input on what sort of user fees it should charge to conduct biosimilar and interchangeable biological product reviews. The recommendations, which will implement fees for 2013 through 2017, must be presented to Congress by January 15, 2012.


May 13, 2011
http://www.burrillreport.com/article-fda_to_issue_guidance_on_biosimilars_by_year_end_.html