On May 31, 2022 Kashiv Biosciences, LLC ("Kashiv" or the "Company") reported 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 (Press release, Kashiv BioSciences, MAY 31, 2022, View Source [SID1234615294]).

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FYLNETRA was developed by Kashiv in Chicago, Illinois in collaboration with Amneal Pharmaceuticals, Inc. ("Amneal"). 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.

This marks the second biosimilar approval Kashiv received this year for products used in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Kashiv and Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen. Kashiv expects both products to launch via its commercial partner, Amneal, over the second half of 2022, along with a full patient support program.

"Building on our successful partnership with Amneal with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar. Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars in the United States. We are excited to build on the momentum as we look towards future approvals to bring high quality biosimilars to the global markets," said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

"The approval of FYLNETRA is our third U.S. oncology biosimilar approval in as many months. Amneal is well positioned in the fast growing $28 billion U.S. biosimilars market as we build our portfolio initially through in-licensing and vertical integration over time. We are very enthusiastic about our future in biopharmaceuticals. Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible," said Chirag and Chintu Patel, Co-Chief Executive Officers for Amneal.

According to IQVIA, U.S. annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales.

Indications: FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

FYLNETRA IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before you take FYLNETRA, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

WARNINGS AND PRECAUTIONS

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue FYLNETRA in patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving FYLNETRA. Discontinue FYLNETRA if sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on FYLNETRA. Consider dose-reduction or interruption of FYLNETRA in patients with kidney injury.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.
The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using FYLNETRA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Aortitis has been reported in patients receiving pegfilgrastim products.
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.
ADVERSE REACTIONS

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.