Novartis International has won FDA approval for a biosimilar of an existing drug. The drug, a copy of Amgen’s Neupogen, is designed to boost white blood cell counts in certain patients. An abbreviated FDA approval pathway for biologic medical products that share most of their properties with an existing, approved biologic product was created by the Biologics Price Competition and Innovation Act, passed as part of President Obama’s healthcare reform package. This, however, marks the first time the FDA has actually approved a biosimilar drug, though a number of others are pending approval.
While this new pathway is expected to save the U.S. healthcare system billions per year, many drug companies and other critics charge that it weakens patent protections and harms research and development by allowing competitors to bring their drugs to market earlier.