The Global. In March 2015, the FDA authorized the first biosimilar drug in the United States. It was Zarxio (filgrastim) from Sandoz to combat infections in cancer patients and which has Neupogen from Amgen as its reference biologic. An approval charged with controversy and that had its final resolution in the courts. Just when one year has just passed since that approval, the North American drug agency goes one step further by announcing the go-ahead for the commercialization of the first biosimilar monoclonal antibody.