Organon's (OGN) biosimilar Poherdy was recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use for a marketing authorization in breast cancer, the regulator said Thursday.
Poherdy will be available as a 420 mg concentrate for solution for infusion, the agency said. Its active substance is pertuzumab, a monoclonal antibody.
Poherdy has comparable quality, safety and efficacy to Perjeta, which was authorized in the European Union in 2013, the regulator said.
Organon shares were up 2.8% in recent premarket activity Friday.