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, 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, via its operating company Fresenius Kabi, and Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, have entered an agreement to provide the integration of the IRO® platform with Fresenius Kabi’s upstream and downstream processing technologies. The successful integration of these leading technology platforms provides a streamlined, closed workflow for cell therapy manufacturing that can reduce process steps, tube- and bag-based transfers, and operator touch time. This collaboration underscores Ori Biotech and Fresenius Kabi’s shared commitment to driving innovation and developing widespread patient access to life-saving cell and gene therapies. All to help bring cell and gene therapies to market faster and more efficiently, in line with #FutureFresenius.

mAbxience, a Fresenius Kabi majority-owned group, and Egis have entered a strategic commercialization agreement for two biosimilar candidates in key Central and Eastern European markets. Fresenius Kabi, an operating company of Fresenius, continues to reinforce its biopharma business and strategic network through this new agreement with Egis. This directly underscores the mutual commitment of both companies to broadening access to essential, high-quality biosimilar therapies in markets where affordability and accessibility are critical. The agreement strengthens Fresenius Kabi’s presence in Central and Eastern Europe and reaffirms its dedication to drive innovation and accessibility of life-saving treatments in global healthcare, all in line with #FutureFresenius.

Fresenius, via its operating company Fresenius Kabi, and Cellular Origins, a TTP Company, have entered an agreement to develop integration strategies for Fresenius Kabi’s portfolio of Cell Therapy Technologies within Cellular Origins’ Constellation™ automation platform. The agreement aims to leverage each company’s expertise in cell and gene therapies (CGTs) for digitally and physically integrating Fresenius Kabi’s suite of cell therapy processing technologies within Cellular Origins’ CGT robotic manufacturing platform Constellation™. Initial focus will be on integration of the Cue® Cell Processing System for automated small volume processing. Driving innovation by building momentum in cell and gene therapy, is a further milestone of #FutureFresenius.

mAbxience, a Fresenius Kabi majority-owned group, and Teva Pharmaceuticals International have entered a second global licensing agreement for an anti PD-1 biosimilar candidate currently in development for the treatment of multiple oncology indications. The agreement covers global markets, including in Europe and the United States. Fresenius Kabi, an operating company of Fresenius, continues to strengthen its biopharma business and strategic network through this new agreement, which builds on the solid foundation of the initial partnership with Teva. This directly underscores the companies’ mutual goal to provide cost-effective, high-quality biosimilar treatments that address critical unmet needs in oncology care. By leveraging expertise and resources, the collaboration continues to drive innovation and accessibility in global healthcare, all in line with #FutureFresenius.

The healthcare group Fresenius has achieved a further milestone in the implementation of #FutureFresenius with the successful completion of the divestment of Vamed’s rehabilitation business to the international private equity firm PAI Partners. Fresenius retains a minority stake of 30 percent in the business. The transaction, which was announced in May 2024, has received all necessary regulatory approvals and the closing conditions have been met. The rehabilitation business which also includes specialized healthcare services in the areas of prevention, acute care and nursing, was Vamed's largest business unit. With approximately 13,000 employees, it provides inpatient and outpatient rehabilitation services to approximately 100,000 patients every year in various European countries.

After having received the European Commission approval just recently, Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the United States (U.S.) Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab). OtulfiTM is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In accordance with the patent settlement between Formycon, Fresenius Kabi and Johnson & Johnson, Fresenius Kabi has the right to market OtulfiTM in the U.S. no later than February 22, 2025. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius. * OtulfiTM (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries ** Stelara® is a registered trademark of Johnson & Johnson

Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the European Commission (EC) granted marketing authorization for FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases. In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius. Stelara® is a registered trademark of Johnson & Johnson