24 September 2018 received a positive opinion from CHMP for its Neulasta 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 fourth team to receive a positive opinion for Neulasta for the EU market. Accord (subsidiary of Intas Pharma) and Coherus received a positive opinion in July 2018, followed by Sandoz (Novartis division) and Cinfa Biotech in September 2018. The global market size of Neulasta is ~USD4.5b (as of CY17; ex-US sales USD600m). Separately, the drug product facility was inspected in April-May 2018 and received the Establishment Inspection Report (EIR) in June 2018. Successful inspections at both its facilities imply minimal regulatory hurdles for sales of pegfilgrastim biosimilar in the US market. BIOS/MYL, leading companies vying for approval in the regulated markets are Apotex, Sandoz, Coherus, Pfizer and Dr.