Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively. 

Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later in H2 of 2025 subject to regulatory approval.

The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.

*Prolia® and Xgeva®* are registered trademarks of Amgen Inc.
**Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries. 

Read the full press release here.

Please click to see full  Prescribing Information for Conexxence®.
Please click to see full  Prescribing Information  for Bomyntra®.
 

Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively. 

Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later in H2 of 2025 subject to regulatory approval.

The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.

*Prolia® and Xgeva®* are registered trademarks of Amgen Inc.
**Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries. 

Read the full press release here.

Please click to see full Prescribing Information for Conexxence®.
Please click to see full Prescribing Information for Bomyntra®.
 

Fresenius announced today that its Operating Company Fresenius Kabi’s ustekinumab biosimilar Otulfi® (ustekinumab-aauz), developed by Formycon AG, is now available in the United States and European Union. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab). 

In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. In September 2024, U.S. FDA and EC approval for both subcutaneous and intravenous formulations was received. Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis in the U.S. Being Fresenius’ fourth biosimilar on the market, the company continues the growth path of its BioPharma platform in line with #FutureFresenius. 

Fresenius announced today that its Operating Company Fresenius Kabi’s ustekinumab biosimilar Otulfi® (ustekinumab-aauz), developed by Formycon AG, is now available in the United States and European Union. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab). 

In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. In September 2024, U.S. FDA and EC approval for both subcutaneous and intravenous formulations was received. Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis in the U.S. Being Fresenius’ fourth biosimilar on the market, the company continues the growth path of its BioPharma platform in line with #FutureFresenius. 

Fresenius, via its operating company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Adaptive Nomogram, an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System. 

The Adaptive Nomogram enables an average 11.6% increase in plasma collection per donation while maintaining safe and effective operation. This enhanced capability will allow plasma centers to improve collection efficiency. Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi reinforces its commitment to improving access to these critical therapies. The clearance received for the Adaptive Nomogram is another milestone in line with #FutureFresenius.
 

Fresenius, via its operating company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Adaptive Nomogram, an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System. 

The Adaptive Nomogram enables an average 11.6% increase in plasma collection per donation while maintaining safe and effective operation. This enhanced capability will allow plasma centers to improve collection efficiency. Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi reinforces its commitment to improving access to these critical therapies. The clearance received for the Adaptive Nomogram is another milestone in line with #FutureFresenius.
 

• Fresenius, through its operating company Fresenius Kabi, is broadening its growing biopharma portfolio through a new licensing agreement with South Korea’s SamChunDang Pharm (SCD).  
• Under the agreement, Fresenius Kabi will exclusively commercialize SCD’s aflibercept biosimilar candidate in the U.S. and several countries in Latin America.  
• Aflibercept is used to treat a range of ophthalmic disorders, including wet age-related macular degeneration.   

Under the agreement, Fresenius Kabi will commercialize the proposed aflibercept biosimilar, a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein, in the US, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico after successful approval by respective health agencies. SCD is responsible for the development, manufacturing, and supply of the drug.

Fresenius Kabi is an operating company of Fresenius that specializes in (bio)pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions.

SCD is based in South Korea and specializes in developing generics and biosimilars for global markets.
 
Aflibercept is a proposed biosimilar referencing Eylea®, an anti-VEGF for the treatment of ophthalmic conditions such as wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). Eylea is commercialized by Regeneron in the US and by Bayer in other countries.

“With the commercialization of the aflibercept biosimilar, we are broadening our product portfolio with a treatment option for ophthalmic diseases. In alignment with our #FutureFresenius strategy, this marks another significant milestone for Fresenius Kabi in fulfilling our strategic objective of enhancing access to biosimilars for patients globally,” said Dr. Sang-Jin Pak, Fresenius Kabi’s President of Business Unit Biopharma.

"We are thrilled to have finalized this agreement and are eager to move forward with the commercialization of our aflibercept biosimilar candidate upon approval. The combination of SCD’s specialized expertise in ophthalmology and Fresenius Kabi’s global commercial strength creates a robust foundation to support our shared objective of improving patient access to more affordable treatment options in ophthalmology," says Mr. Chun In Seok, Chief Executive Officer at SCD.

*Eylea® is a registered trademark of Regeneron.

• Fresenius, through its operating company Fresenius Kabi, is broadening its growing biopharma portfolio through a new licensing agreement with South Korea’s SamChunDang Pharm (SCD). 
• Under the agreement, Fresenius Kabi will exclusively commercialize SCD’s aflibercept biosimilar candidate in the U.S. and several countries in Latin America.  
• Aflibercept is used to treat a range of ophthalmic disorders, including wet age-related macular degeneration.   

Under the agreement, Fresenius Kabi will commercialize the proposed aflibercept biosimilar, a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein, in the US, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico after successful approval by respective health agencies. SCD is responsible for the development, manufacturing, and supply of the drug.

Fresenius Kabi is an operating company of Fresenius that specializes in (bio)pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions.

SCD is based in South Korea and specializes in developing generics and biosimilars for global markets.
 
Aflibercept is a proposed biosimilar referencing Eylea®, an anti-VEGF for the treatment of ophthalmic conditions such as wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). Eylea is commercialized by Regeneron in the US and by Bayer in other countries.

“With the commercialization of the aflibercept biosimilar, we are broadening our product portfolio with a treatment option for ophthalmic diseases. In alignment with our #FutureFresenius strategy, this marks another significant milestone for Fresenius Kabi in fulfilling our strategic objective of enhancing access to biosimilars for patients globally,” said Dr. Sang-Jin Pak, Fresenius Kabi’s President of Business Unit Biopharma.

"We are thrilled to have finalized this agreement and are eager to move forward with the commercialization of our aflibercept biosimilar candidate upon approval. The combination of SCD’s specialized expertise in ophthalmology and Fresenius Kabi’s global commercial strength creates a robust foundation to support our shared objective of improving patient access to more affordable treatment options in ophthalmology," says Mr. Chun In Seok, Chief Executive Officer at SCD.

*Eylea® is a registered trademark of Regeneron.

Fresenius, through its operating company Fresenius Kabi, announced today that Epinephrine Injection, USP, is now available in the United States as the first generic version of Epinephrine in a 1mg/1mL vial for U.S. customers. Epinephrine Injection, USP is a prescription medicine used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock; for emergency treatment of allergic reactions including anaphylaxis and for induction and maintenance of mydriasis during intraocular surgery.

In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion in recent years to expand and update its U.S. pharmaceutical production as well as distribution facilities. More than 70 percent of the product units shipped in the U.S. by Fresenius Kabi are drugs listed on the FDA’s Essential Medicines List.
 

Fresenius, through its operating company Fresenius Kabi, announced today that Epinephrine Injection, USP, is now available in the United States as the first generic version of Epinephrine in a 1mg/1mL vial for U.S. customers. Epinephrine Injection, USP is a prescription medicine used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock; for emergency treatment of allergic reactions including anaphylaxis and for induction and maintenance of mydriasis during intraocular surgery.

In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion in recent years to expand and update its U.S. pharmaceutical production as well as distribution facilities. More than 70 percent of the product units shipped in the U.S. by Fresenius Kabi are drugs listed on the FDA’s Essential Medicines List.