FDAnews Drug Daily Bulletin

As FDA Dawdles on Interchangeability, Expert Questions Whether It’s Doable

Aug. 22, 2012
Companies blazing a path in the biosimilars arena likely have a long wait before their products can achieve an interchangeability designation, as the FDA admits to slow progress on that standard. And even after the standard is set, brand companies may have the only chance at getting an interchangeable designation, Jonathan Loeb, a partner at Dechert, said. Instead of developing products from scratch, they could create interchangeable versions of their own approved biologics, similar to how brand drugmakers create authorized generics.
Washington Drug Letter