Sandoz`s Biologic Ziextenzo (pegfilgrastim-bmez) Receives Approval in the U.S.
“ Innovative design enables five-minute pegfilgrastim-cbqv delivery time “ “ Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...
Mylan`s Biologic Fulphila (pegfilgrastim) Receives Approval in the U.S.
Sandoz`s Biologic Ziextenzo (pegfilgrastim) Receives Approval in the U.S.
The biologics license application (BLA) seeking the approval of the on-body injector (OBI) presentation of pegfilgrastim-cbqv (Udenyca), a biosimilar of pegfilgrastim (Neulasta), has been resubmitted to the FDA for review.1
CuraTeQ Biologics s.r.o.'s, a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has requested to withdraw the applications for Marketing Authorization of ZEFYLTI (a filgrastim biosimilar) and DYRUPEG (a pegfilgrastim biosimilar) has been accepted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)
LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for Stimufend® (pegfilgrastim-fpgk). Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to Stimufend is effective for patients administered Stimufend on and after April 1, 2023. The KABICARE™ patient services hub is available to facilitate successful access and reimbursement.
FDA Approves UDENYCA® Autoinjector
Stimufend® (pegfilgrastim-fpgk) Now Available in the United States
Coherus' Biologic Udenyca (Pegfilgrastim) Receives Approval in the U.S.