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Neulasta News

U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta

Posted 6 Jun 2018 by Drugs.com

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 ...

1st 'Biosimilar' To Neulasta, Fulphila (Pegfilgrastim), OK'd to Prevent Chemo-Related Infections

Posted 5 Jun 2018 by Drugs.com

TUESDAY, June 5, 2018 – The first "biosimilar" drug to Neulasta, designed to ward off infections related to chemotherapy, has been approved by the U.S. Food and Drug Administration. Fulphila (pegfilgrastim) is approved for people with symptoms of febrile neutropenia, which is characterized by fever and other signs of infection such as low white-blood-cell count, the FDA said in a news release. ...

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Related Condition Support Groups

Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation

Neulasta Patient Information at Drugs.com