Posted from: Tuesday, December 11, 2018 - 04:42 PM - Present

Udenyca Approved as Neulasta Biosimilar

November 2, 2018 – The U.S. FDA has approved Udenyca™ (pegfilgrastim-cbqv), manufactured by Coherus BioSciences, Inc., as a biosimilar for Amgen’s Neulasta® (pegfilgrastim)‎. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia.

Recommended dosing with Udenyca is 6mg given by subcutaneous injection once per chemotherapy

cycle. The product should be administered at least 14 days before or 24 hours after the administration of cytotoxic chemotherapy. Weight-based dosing should be used for pediatric patients who are less than 45kg (99 pounds).

Udenyca is the second Neulasta biosimilar to win FDA approval. Mylan’s Fulphila™ (pegfilgrastim-jmdb) received the FDA’s nod in June 2018 and launched the following month. Fulphila carries the same indication as Udenyca.

Unlike its biosimilars, Neulasta has a second indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Coherus BioSciences plans to launch Udenyca in January 2019, at a list price of $4,175 per unit, 33% less than the list price of Neulasta.

Last Updated Monday, September 16, 2019 - 08:28 AM.