Source: Mylan N.V. & reported by http://www.prnewswire.com/
BENGALURU, India, HERTFORDSHIRE, England and PITTSBURGH, July 21, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review, Mylan's Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Mylan and Biocon, who have co-developed the proposed biosimilar, received EMA's acceptance of the submission for review. In addition to analytical, functional and pre-clinical data, the application includes clinical data from pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016. The results from the studies are expected to be presented at the prestigious European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in Oct. 2016.
Read more: http://www.prnewswire.com/news-releases/mylan-and-biocon-announce-regulatory-submission-for-proposed-biosimilar-pegfilgrastim-accepted-for-review-by-european-medicines-agency-300302009.html