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US FDA accepts biologics license application from Lupin for pegfilgrastim biosimilar expresspharma
June 03, 2021
Lupin announced that the US FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.
Biocon and Mylan Launch Fulphila, Biosimilar Pegfilgrastim, in Australia expresspharma
April 15, 2020
The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist.
EU OKs Mundipharma’s Neulasta biosimilar contractpharma
November 28, 2018
The Mundipharma network of independent associated companies says European regulators have approved use of Pelmeg, a biosimilar of Amgen’s white blood cell booster Neulasta.
US OKs first biosimilar of Amgen's Neulasta pharmatimes
July 12, 2018
Mylan and Biocon's Fulphila has become the first biosimilar of Amgen's Neulasta to be approved by the US Food and Drug Administration.
Amgen's $3.9B Neulasta to face U.S. biosim 'in the coming weeks' with Mylan approval fiercepharma
June 06, 2018
With an FDA approval for Fulphila, the first U.S. biosimilar to Amgen's Neulasta, Mylan will have its chance to launch a biosim to one of the biggest drug targets in the U.S. market.