BAD HOMBURG, Germany–(BUSINESS WIRE)–Sep 6, 2022–
Fresenius Kabi, a global healthcare company specializing in pharmaceuticals, medical technologies and nutritional products for critical and chronic diseases, today announced that the United States Food and Drug Administration (FDA) has approved its biosimilar, Stimufend ® (pegfilgrastim -fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The company plans to launch the product in a prefilled syringe early next year and in an on-body injector after FDA approval.
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Fresenius Kabi has received FDA approval for the biosimilar Stimufend (pegfilgrastim-fpgk). The company plans to launch Stimufend in the United States in early 2023. (Photo: Business Wire)
Earlier this year, the company received European Commission (EC) marketing authorization for Stimufend® and intends to launch its biosimilar pegfilgrastim in pre-filled syringes in Europe in the fall.
“This is a strategic step for Fresenius Kabi in one of the largest and fastest growing biopharmaceutical markets,” said Michael Sen, CEO of Fresenius Kabi and CEO-designate of Fresenius. “The company is therefore expanding its presence and position in the highly attractive US biosimilars market, in line with Vision 2026.”
Stimufend ® is Fresenius Kabi’s first US-approved therapy in its biosimilar portfolio, expanding its extensive oncology portfolio to treat even more cancer patients in the United States. The company’s biosimilar pegfilgrastim is a supportive medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential for preventing or fighting infections, a common fatal risk in patients receiving myelosuppressive chemotherapy.
Dr. Michael Schönhofen, CEO of Fresenius Kabi and Member of the Fresenius Kabi Board of Directors, said: “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 are contributing to the broader adoption of biosimilars and a sustainable healthcare system in the United States”
The approval of Stimufend ® (pegfilgrastim – fpgk) is based on the review of a comprehensive set of data and a body of evidence demonstrating a high degree of similarity to the reference product. No clinically significant differences in terms of safety and immunogenicity were observed.
About Stimufend, a biosimilar to pegfilgrastim
Stimufend®, a biosimilar pegfilgrastim by Neulasta®**, is a leukocyte stimulating factor indicated to decrease the incidence of infections, manifesting as febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with an 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, may occur following administration of pegfilgrastim products. Look for an enlarged spleen or splenic rupture in patients who report pain in the upper left abdomen or shoulder. Acute respiratory distress syndrome (ARDS) may occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and pulmonary infiltrates or respiratory distress after receiving Stimufend. Discontinue Stimufend in patients with ARDS. Serious allergic reactions, including anaphylaxis, may occur in patients receiving pegfilgrastim products. The majority of the reported events occurred during the initial exposure and may reappear a few days after stopping the initial anti-allergic treatment. Permanently discontinue Stimufend in patients with severe allergic reactions. In patients with sickle cell trait or disease, serious and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products. Stop Stimufend if you have a sickle cell crisis. Glomerulonephritis has occurred in patients receiving pegfilgrastim products. Diagnoses based on azotemia, haematuria, proteinuria and kidney biopsy. Generally, events resolved after dose reduction or discontinuation of pegfilgrastim products. If suspected, investigate the cause and if the cause is probable, consider dose reduction or discontinuation of Stimufend.
Leukocytosis – an increase in white blood cell count of 100 x 109/L was observed. Monitoring of complete blood count (CBC) during treatment with Stimufend is recommended.
Thrombocytopenia – Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet count. Capillary leak syndrome (CLS) has been reported after administration of G-CSF, including pegfilgrastim products.
SLC is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and can be life-threatening if treatment is delayed. Patients with symptoms should be closely monitored and given standard symptomatic treatment, which may include the need for intensive care.
Potential for tumor growth stimulating effects on malignant cells – The G-CSF receptor has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth promoter for any type of tumor, including myeloid malignancies and myelodysplasia, conditions 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 combination with chemotherapy and/or radiation therapy in patients with breast and lung cancer . Monitor patients for signs and symptoms of MDS/AML in these settings.
Cases of aortitis have been reported in patients receiving pegfilgrastim products. It can occur as early as the first week after the start of treatment. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, C-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without a known etiology. Stop Stimufend if aortitis is suspected.
Nuclear imaging – increased bone marrow hematopoietic activity in response to growth factor therapy has been associated with transient positive changes in bone imaging. This should be considered when interpreting bone imaging results. The most common side effects are bone pain and pain in the extremities.
This Important Safety Information does not include all of the information needed to use Stimufend safely and effectively. Full prescribing information for Stimufend is available here. Stimufend Injection: 6 mg/0.6 mL in a single dose pre-filled syringe for manual use only.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com.
For more information on biosimilars, please visit https://biosimilars.fresenius-kabi.com.
For more information on biosimilars in the United States, please visit https://biospecialized.com.
About Fresenius Kabi
Fresenius Kabi is a global healthcare company specializing in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The Company’s products and services are used to help care for critically ill and chronically ill patients.
Fresenius Kabi’s product portfolio includes a full range of generic intravenous drugs, infusion therapies and clinical nutrition products as well as the delivery devices for these products. In the area of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, Fresenius Kabi’s first biosimilar product was launched. Within the scope of transfusion medicine and cellular therapies, Fresenius Kabi offers products for the collection of blood components and extracorporeal therapies.
With its “caring for life” corporate philosophy, the company is committed to putting essential medicines and technologies into the hands of the people who help patients and to finding the best answers to the challenges they face.
Fresenius Kabi employs over 41,000 people worldwide. In 2021, the company achieved a turnover of more than 7.2 billion euros. Fresenius Kabi AG is a 100% subsidiary of the healthcare group Fresenius SE & Co. KGaA.
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, for example, changes in business, economic and competitive conditions, regulatory reforms, clinical trial results, exchange rate fluctuations, uncertainties in litigation or investigative procedures, and the availability of financing. Fresenius Kabi disclaims any responsibility for updating the forward-looking statements contained in this press release.
Board of Directors: Michael Sen (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr Christian Hauer, Dr Michael Schönhofen.
Chairman of the Supervisory Board: Stephan Sturm.
Headquarters: Bad Homburg, Germany
Commercial register: Amtsgericht Bad Homburg – HRB 11654
* Stimufend ® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in certain countries
** Neulasta® is a registered trademark of Amgen Inc.
*** This is a long-acting form of filgrastim (recombinant human granulocyte-colony stimulating factor or G-CSF) that is used to stimulate the production of white blood cells (neutrophils).
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SOURCE: Fresenius Kabi
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PUBLISHED: 06/09/2022 12:45 / DISK: 06/09/2022 12:47