One of the very things that could make a biosimilar a more affordable alternative to its reference biologic may be the biggest marketing challenge for the follow-ons in the U.S., at least initially.
Instead of the safety and efficacy trials that have been the warriors of FDA approval, biosimilar sponsors follow a science-driven, mechanistic approach in which they seek to demonstrate a high level of similarity by testing their candidate against the reference product in at least one indication. If all goes well, the biosimilar could be approved for all the indications of the innovator while forgoing expensive safety and efficacy trials for each disease or condition.
The EU and most of the countries with a biosimilar path allow or encourage such extrapolation. And when the FDA crowned Sandoz Inc.'s Zarxio as the first U.S. biosimilar, it approved a label that mirrored that of the reference product, Amgen Inc.'s Neupogen (filgrastim). (See