Releuko (filgrastim-ayow) / Kashiv Biosci, Amneal - LARVOL DELTA

Changes in US payer biosimilar coverage policies of granulocyte colony-stimulating factor products (AMCP 2024) - "For filgrastim biosimilars, 84% of payers preferred Zarxio, whereas Neupogen, Nivestym, and Releuko were most commonly nonpreferred...For pegfilgrastim biosimilars, 62% of payers preferred Ziextenzo, 60% preferred Neulasta, and 55% preferred Fulphila, whereas Nyvepria, Fylnetra, and Stimufend were most commonly nonpreferred. Prefer- ence for Udenyca was split, with 45% of payers preferring this agent and 45% of payers listing it as nonpreferred... Payer policies for granulocyte colony stimu- lating factor biosimilars indicated that Neulasta has retained much of its preferred status, whereas Neupogen is often nonpreferred. In both cases, average time to policy addition was about 4 months after FDA approval. Further, pegfil- grastim policies had more updates to the preferred product status than filgrastim policies, possibly because of more pegfilgrastim biosimilars being approved and marketed."

Amneal Launches Second Biosimilar with RELEUKO (filgrastim-ayow) in the United States (Businesswire) - "Amneal Pharmaceuticals,...announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois."

Biosimilar launch • Febrile Neutropenia • Neutropenia • Oncology

Biosimilars May Reduce Disparities in Febrile Neutropenia Treatment (Oncology Nursing News) - "'We [now] have several biosimilars available in the US and around the world, [with the reference agents] filgrastim and pegfilgrastim' said Crawford, in a presentation on new and emerging agents on outcomes of febrile neutropenia during the 2022 Supportive Care in Cancer Annual Meeting.'The potential impact of this is significant; [it represents] greater patient access, greater competition between the companies, and fostered innovation.'"

Media quote

Kashiv Biosciences Receives Approval for Its First Biosimilar RELEUKO (filgrastim-ayow) (Businesswire) - "Kashiv Biosciences...announced the U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen®. The product will be marketed under the proprietary name RELEUKO....RELEUKO was developed in collaboration with Amneal Pharmaceuticals, Inc. and is expected to launch in the third quarter of 2022. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Kashiv is planning for a pegfilgrastim biosimilar referencing Neulasta® to also be approved in 2022."

Biosimilar launch • BLA • Neutropenia • Oncology

FDA accepts Adello Biologic’s biosimilar Biologics License Application for a proposed filgrastim biosimilar (Businesswire) - "U.S.-based Adello Biologics today announced that U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for a biosimilar candidate referencing Neupogen® (filgrastim)."

BLA • Biosimilar

Amgen settles patent suit with Amneal on Neupogen biosimilar (Bloomberg Law) - "Amgen had claimed that Amneal and Kashiv’s proposed biosimilar version of Neupogen infringed patents for the cancer drug. No details were provided in notice of agreement, approved Monday in federal court in Newark, New Jersey."

Patent