Tag Archives: Neulasta

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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8 December
New Phase 1 Data Shows Sandoz’s Proposed Biosimilar Pegfilgrastim Matches Reference Medicine

HOLZKIRCHEN, Germany, Dec. 8, 2017 /PRNewswire/ — Sandoz, a division of Novartis and the global leader in biosimilars, today announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta®*1. The Phase I study, conducted in healthy volunteers, confirmed …
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12 June
FDA Rejects Coherus’ Application for Proposed Biosimilar to Amgen’s Neulasta

REDWOOD CITY, Calif., June 12, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway. The CRL primarily …
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17 May
Cinfa’s Pegfilgrastim Biosimilar Candidate Demonstrates Positive Results in Second Clinical Study

PAMPLONA, Spain | May 17, 2017 | Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta(R)(pegfilgrastim) to treat chemotherapy-induced neutropenia. The trial demonstrated comparability of B12019 and its reference product Neulasta …
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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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18 November
FDA Accepts Sandoz’ Submission for its Biosimilar Version of Amgen’s Neulasta

Holzkirchen, November 18, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Neulasta® (pegfilgrastim)* – a recombinant human granulocyte colony-stimulating …
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