22 October 2018 received a positive opinion from CHMP for its Herceptin biosimilar for the EU market. BIOS/Mylan also have in place the EU good manufacturing practices (GMP) certification for their drug product and drug substance facilities. Biocon/Mylan would be the fifth team to receive a positive opinion for Herceptin for the EU market. Amgen received positive opinion from CHMP in Mar-18 and is in process to get approval EU commission. Though the market size is considerable, there is settlement in place between Mylan and Roche for launching the same in EU market. The inspection history at BIOS facilities (both drug substance as well as drug product) indicates successful compliance in place and would not be a hurdle for approval of any product. Recently, BIOS successfully completed the USFDA inspection (periodic GMP inspection) at its drug substance facility at Bengaluru with zero 483s.