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 …
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18 January
Sandoz Announces Exclusive Global Collaboration with Biocon on Next-Generation Biosimilars

Holzkirchen, 18 January 2018 – Sandoz, a Novartis division and the global leader in biosimilars, today announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility …
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14 July
FDA Committee Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, July 13, 2017/PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible …
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17 February
FDA Accepts for Review Mylan’s Application for Proposed Biosimilar Pegfilgrastim

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Feb. 16, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), for filing through the …
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11 January
FDA Accepts Mylan and Biocon’s BLA for Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through …
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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 …
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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 …
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