Tag Archives: Biocon

June, 2018

  • 5 June

    FDA Approves Mylan and Biocon’s Fulphila, the First Biosimilar to Neulasta

    HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018/PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever …

January, 2018

July, 2017

February, 2017

January, 2017

November, 2016

  • 9 November

    Mylan Seeks FDA Approval for Proposed Biosimilar Trastuzumab

    HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Nov. 8, 2016 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This …

May, 2015

  • 11 May

    Two Biocon Biosimilars Enter Late-Stage Studies

    Asia’s Biocon recently announced an update on clinical progress of its programs, saying that two of its biosimilar candidates have entered late-stage studies. The company has partnered with Britain’s Mylan on these two molecules. The companies’ pegfilgrastim (PEG-G-CSF) and Adalimumab have entered global Phase III clinical trials, which will assess …