Stimufend® (pegfilgrastim-fpgk) a Fresenius Kabi biosimilar receives FDA approval

Earlier this year, the company received the European Commission's (EC) marketing authorization for Stimufend® and it intends to launch its pegfilgrastim biosimilar in a prefilled syringe in Europe in the fall.

"This is a strategic milestone for Fresenius Kabi in one of the most important and fast-growing markets for biopharmaceuticals," said Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius. "The company consequently expands its presence and position in the highly attractive U.S. biosimilars marketplace in line with Vision 2026."

Stimufend^® is Fresenius Kabi's first U.S.-approved therapy in its biosimilar portfolio, expanding its extensive Oncology portfolio to treat even more cancer patients in the U.S. The company's pegfilgrastim biosimilar is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy.

Dr. Michael Schönhofen, Fresenius Kabi's Chief Operating Officer and Member of the Fresenius Kabi Management Board, said: "The FDA approval of our pegfilgrastim biosimilar is an important step to better support the treatment experience and clinical outcomes of cancer patients in the United States. With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the U.S."

The approval for Stimufend^® (pegfilgrastim-fpgk) is based on a review of a comprehensive data package and a totality of evidence that demonstrated a high degree of similarity with the reference product. No clinically meaningful differences in safety and immunogenicity were observed.

About Stimufend, a pegfilgrastim biosimilar

Stimufend^®, a pegfilgrastim biosimilar medicine of Neulasta^®**, 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.***

Stimufend^® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Stimufend (pegfilgrastim-fpgk) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis. Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain. Acute Respiratory Distress Syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Stimufend. Discontinue Stimufend in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Stimufend in patients with serious allergic reactions.

In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products. Discontinue Stimufend if sickle cell crisis occurs. Glomerulonephritis has occurred in patients receiving pegfilgrastim products. Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy. Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim products. If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Stimufend.

Leukocytosis - increased white blood cell counts of 100 x 10⁹/L have been observed. Monitoring of complete blood count (CBC) during Stimufend therapy is recommended.

Thrombocytopenia - thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts. Capillary Leak Syndrome (CLS) has been reported after G-CSF administration, including pegfilgrastim products.

CLS is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells - G-CSF receptor has been found on tumor cell lines. 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) have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Stimufend if aortitis is suspected.

Nuclear Imaging - increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results. Most common adverse reactions are bone pain and pain in extremity.

This Important Safety Information does not include all the information needed to use Stimufend safely and effectively. Stimufend full Prescribing Information can be found here.
Stimufend Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800‐551‐7176, option 5, or FDA at 1‐800‐FDA‐1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

For more information about biosimilars, please visit https://biosimilars.fresenius-kabi.com
For more information about biosimilars in the U.S., please visit https://biospecialized.com

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