Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend® (pegfilgrastim – fpgk)

• Fresenius Kabi’s first approved U.S. biosimilar

• Provides accessible, high-quality treatment option for U.S. cancer patients undergoing chemotherapy to reduce the incidence of infection as manifested by febrile neutropenia

• Broadens the company’s global biosimilars portfolio focused on oncology and immunology

• Another key milestone in the company’s Vision 2026 growth strategy

BAD HOMBURG, Germany–(BUSINESS WIRE)–#FreseniusKabi–Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved its biosimilar, Stimufend^® (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company expects to launch the product in a prefilled syringe early next year and in an on-body injector following 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^® (pegfilgrastim – fpgk) 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 www.fda.gov/medwatch.com.

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.

About Fresenius Kabi

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients.

Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

With its corporate philosophy of “caring for life”, the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi employs more than 41,000 people worldwide. In 2021, the company reported sales of more than €7.2 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

For more information visit the company’s website at www.fresenius-kabi.com.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Michael Sen (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen.

Chairman of the Supervisory Board: Stephan Sturm.

Registered Office: Bad Homburg, Germany

Commercial Register: Amtsgericht Bad Homburg – HRB 11654

* Stimufend^® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries

** Neulasta^® is a registered trademark of Amgen Inc.

*** It is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or G-CSF) which serves to stimulate the production of white blood cells (neutrophils).

Contacts

Matt Kuhn, (847) 550-5751

[email protected]