FDA approval options for follow-on biologics


Paul A. Calvo and Timothy Shea, Jr

With the passage of the Biologics Price Competition and Innovation Act in the US last year, there is now a new option for parties seeking FDA approval of their follow-on biological product.

Follow-on biologics, new versions of previously approved biopharmaceutical products intended to mimic the therapeutic effect of the approved product and compete for market share, have been approved by the FDA either as completely new biological products requiring submission of a full Biologics License Application (BLA) or under section 505(b)(2) of the Federal Food Drug and Cosmetic Act.

With the passage of the Biologics Price Competition and Innovation Act (BPCI) in 2010, follow-on biologics manufacturers were presented with a third, abbreviated, pathway for approval. Each alternative has specific requirements and certain advantages and disadvantages compared with the others. Entities considering bringing a follow-on biologic to market must carefully consider the relative pros and cons of each route in determining which is best for a given product.

While the cost of clinical trials and the possibility of data or market exclusivity will often be the primary considerations, manufacturers should also consider factors such as the nature of differences between the follow-on product and the approved product, the likely potential market share the follow-on will capture and the desire for patent certainty at the time of launch.

FDA, pharmaceuticals, biologics, Biologics Price Competition and Innovation Act