5 June 2018 Neulasta biosimilar version) was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to Neulasta. Because of non-interchangability clause, BIOS/MYL would have to invest marketing efforts to garner business from this product. Other than BIOS/MYL, leading companies vying for approval in regulated markets are Apotex, Sandoz, Coherus, Pfizer and Dr Reddys. However, Apotex has not yet received approval for its BLA (biologic license application) version from USFDA. Coherus would be submitting the day-180 responses by the end of May and expects further opinion from advisory group CHMP (Committee for Medicinal Products for Human Use) on day-210, which is around end of June 2018. EU regulators are reviewing marketing authorization applications filed by BIOS/MYL, Sandoz and Cinfa Biotech. Specifically, BIOS/MYLs MAA was accepted in November 2017, Cinfa Biotechs in October 2017, and Sandoz filed in October 2017.