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Biocon and Mylan launch fulphila — biosimilar to pegfilgrastim, in Canada expresspharma
April 29, 2020
The approval of fulphila was based on a comprehensive package of analytical, non-clinical 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.
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.
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.
FDA Approves Fulphila drugs
June 12, 2018
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 Fulphil
Mylan and Biocon's Fulphila becomes first FDA-approved biosimilar of Amgen's Neulasta pharmafile
June 07, 2018
The FDA has granted approval to Mylan and Biocon’s Fulphila, the first biosimilar version of Amgen’s Neulasta (pegfilgrastim) to be approved in the US.
USFDA approves Mylan and Biocon’s Fulphila biospectrumasia
June 05, 2018
Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection following myelosuppressive chemotherapy.