ARTICLE | Regulation
Biosimilar schism
How biosimilars players have split over competing business models
February 10, 2014 8:00 AM UTC
FDA and state governments are finalizing ground rules that will determine whether the U.S. marketplace for biosimilars will look more like specialty pharmaceuticals, or evolve into a model that has more in common with the generic drug marketplace.
For years, innovator biologics manufacturers battled companies that wanted to create an American biosimilars industry, skirmishing over the scientific and legal standards for demonstrating similarity...