The Bengaluru site also received an EU certification of good manufacturing practice in June of this year, and the FDA in October approved the company's drug product filling line for 150-mg vials of trastuzumab after a September inspection. In a statement announcing the EIR, Christiane Hamacher, PhD, the chief executive officer of Biocon Biologics, said, "The EIR for this facility reaffirms our manufacturing capabilities for high quality biosimilars to serve the needs of patients in the [United States]." Hamacher added that the company's biosimilar pegfilgrastim, Fulphila, for which it partners with Mylan, is already available in the United States, and that Biocon plans to make its biosimilar trastuzumab, Ogivri, commercially available "soon, leading to tremendous cost savings to the US healthcare system."