In a September 20, 2011, Analysis & Insight article, GEN magazine focuses on a recent New England Journal of Medicine discussion by Food and Drug Administration (FDA) officials about developing an approval pathway for biosimilar pharmaceuticals.

Additional information about the FDA article appears in Issue 19 of this Bulletin. Noting that the agency has revealed its plan in broad strokes only, the GEN article discusses some of the open issues with Shook, Hardy & Bacon Life Sciences & Biotechnology Practice Co-Chair Madeleine McDonough.

According to McDonough, “early communication and collaboration” between the agency and biosimilar developers will likely be required and could involve “higher fees” to fund the product reviews that will be required. She noted, “The medical risks are going to depend on how close the biosimilar is to a reference product and what the hypothetical mechanism of action would be that could cause adverse effects or untoward effects. And I don’t think you can do that with some broad brush. I think it’s really going to be compound specific.” Commenting on recently issued draft European guidelines on biosimilars, McDonough said, “It used to be that a lot of companies wanted to get FDA approval first because so many countries relied on FDA approval to shorten the pathway to approval in those countries. I wonder if, at least for biosimilars, that whole paradigm will be reversed and that biosimilars will be approved far later in the United States than in Europe.”

The article concludes, “The draft guidance that FDA eventually releases should go far toward bringing more lower-cost biosimilars to market—one ostensible purpose of healthcare reform. How far it goes and how helpful it is to biologic drug developers will depend on how many of the blanks left by its article in NEJM FDA fills in over the next few weeks.”