As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the United States. Mylan ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved Fulphila, the first biosimilar to pegfilgrastim, to decrease risk for infection, as suggested ...

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 ...

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, April 28, 2020 /CNW/ -- Mylan N.V. and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the launch of Fulphila ®, a biosimilar to ...

The Food and Drug Administration (FDA) approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to reduce the risk for febrile neutropenia in patients treated with ...

Damineh Morsali PH.D., Robert Schwartz Ph.D. Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation ...

Fulphila will be available as a 6mg/0.6mL single-dose prefilled syringe for subcutaneous (SC) injection. The approval was supported by nonclinical and clinical data (including pharmacokinetic, ...

The U.S. Food and Drug Administration has approved the first biosimilar to pegfilgrastim (Neulasta, Amgen), a granulocyte colony-stimulating factor used to reduce infection risk in patients with ...

US pharmaceutical expenditures have increased rapidly, and biologics are largely to blame. These drugs treat serious conditions such as cancer, inflammatory bowel diseases, and neurologic conditions, ...

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile ...