Pharma Focus Europe

Amneal Launches Third Biosimilar with FYLNETRA™ in the United States

Wednesday, May 17, 2023

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta® in a pre-filled single-dose syringe. FYLNETRA™ 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 product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois. The J-Code (Q5130) from the Centers for Medicare & Medicaid Services (CMS) for FYLNETRA™ has been approved and is active.

“FYLNETRA marks our third U.S. biosimilar launch since late last year. We are excited to be contributing to this next wave of affordable medicines, and we are well positioned to drive access across patients, providers, and payors. Although it’s only the early innings for the growing biosimilars market, we are focused on becoming a key player over the long-term. These first three launches are just the start for Amneal in biosimilars,” said Harsher Singh, SVP of Amneal Biosciences division.

“We are pleased to launch the FYLNETRA biosimilar. This launch builds on our successful partnership with Amneal and the good uptake we are seeing of the RELEUKO biosimilar, which was launched in the fourth quarter of 2022. Kashiv is one of a few companies based in the United States to manufacture and launch multiple biosimilars. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years,” said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

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.

About FYLNETRA

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.

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.
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