Fylnetra (pegfilgrastim-pbbk) / Kashiv Biosci, Amneal, JAMP Pharma - LARVOL DELTA

Open Label Randomized Comparative Crossover Pharmacokinetic and Immunogenicity Study (clinicaltrials.gov) - P1 | N=180 | Active, not recruiting | Sponsor: Kashiv BioSciences, LLC

New P1 trial • Febrile Neutropenia • Hematological Disorders • Neutropenia

Kashiv BioSciences, LLC Obtains Marketing Authorization for Pegfilgrastim Injection from Health Canada (Businesswire) - "Kashiv BioSciences, LLC...today announced that Health Canada has granted marketing authorization for its Pegfilgrastim Injection, enabling its commercial launch in this market. This marks an important step in Kashiv’s strategy to expand access to high-quality biosimilars in global markets....Pexegra is a long-acting G-CSF biosimilar indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs."

Canada approval • Solid Tumor

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Sep 2027 ➔ Dec 2027 | Trial completion date: Sep 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

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 Third Biosimilar with FYLNETRA (pegfilgrastim-pbbk) in the United States (Businesswire) - "Amneal Pharmaceuticals, Inc...announced the commercial launch of FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta^® in a pre-filled single-dose syringe....According to IQVIA^®, U.S. annual sales for pegfilgrastim for the 12 months ended March 2023 were $2.6 billion, of which $908 million represented biosimilar sales."

Launch • Sales • 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 Achieves Second U.S. Biosimilar Approval with FYLNETRA (pegfilgrastim-pbbk) (Businesswire) - "Kashiv Biosciences...is pleased to announce that the U.S. Food and Drug Administration ('FDA') has approved its Biologics License Application ('BLA') for pegfilgrastim-pbbk, a biosimilar referencing Neulasta®. The product will be marketed under the proprietary name FYLNETRA."

BLA • Febrile Neutropenia • Hematological Disorders • Neutropenia

Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA (pegfilgrastim-pbbk) (Businesswire) - "Amneal Pharmaceuticals, Inc...announced that the U.S. Food and Drug Administration ('FDA') has approved the Company’s Biologics License Application ('BLA') for pegfilgrastim-pbbk, a biosimilar referencing Neulasta®. The product will be marketed under the proprietary name FYLNETRA™....Amneal received approval of Releuko® (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen®, and Alymsys® (bevacizumab-maly), a bevacizumab biosimilar referencing Avastin®. Amneal expects to launch these three products over the second half of 2022, along with a full patient support program."

Biosimilar launch • BLA • Oncology

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