Pharma Blog Watch

The Future of Biogenerics (Patent Baristas)
In his blog, Stephen Albainy-Jenei writes about a recent announcement by FDA Commissioner Andrew von Eschenbach that, once an approval pathway is established, generic biologics would be considered similar to brand drugs, not interchangeable. "This is similar to the approach of the EU as used by the European Medicines Agency," he points out.

"Using the existing mechanisms for approving generic versions of biogeneric drugs involves two problems: (a) proving that the generic drug is identical to the brand-name active ingredient, dosage form, route of administration, conditions of use (i.e., labeling) and dosage strength; and (b) proving that it is bioequivalent to the brand-name drug."

"With biogenerics, you would have to show that the two biologics, made using different processes, contain the same ingredient. Then, you would have to prove that the two products are bioequivalent, especially when analytical methodology often does not exist or is proprietary to the brand-name product. This would be quite difficult absent clinical studies."