Tag Archives: Fresenius Kabi

Fresenius Kabi Secures Global Rights to PB016 Vedolizumab Biosimilar from Polpharma Biologics

(IN BRIEF) Fresenius Kabi has licensed rights from Polpharma Biologics to commercialize the vedolizumab biosimilar candidate PB016 globally—except in the Middle East and North Africa—once approved. Vedolizumab treats Crohn’s disease and ulcerative colitis, and PB016 references Takeda’s Entyvio®. The transaction … Read the full press release

European Commission approves Conexxence and Bomyntra denosumab biosimilars from Fresenius Kabi for all reference indications, boosting access and the #FutureFresenius Biopharma agenda

(IN BRIEF) The European Commission has approved Fresenius Kabi’s denosumab biosimilars, Conexxence® and Bomyntra®, for all uses of the originator product. These include osteoporosis treatment for postmenopausal women and at-risk men, mitigation of treatment-related bone loss, prevention of skeletal complications … Read the full press release

Fresenius Kabi’s Portugal Plant Becomes First to Earn BSI Kitemark for AMR-Safe Ceftriaxone Production

(IN BRIEF) Fresenius Kabi’s Santiago de Besteiros plant in Portugal has secured BSI Kitemark™ Certification for Minimized Risk of AMR in its Ceftriaxone production, confirming compliance with the AMR Industry Alliance’s Antibiotic Manufacturing Standard. Key measures include stringent controls to … Read the full press release

Lizl Veldsman Wins Top ASPEN Award for Groundbreaking ICU Nutrition Study

(IN BRIEF) South African clinical dietitian Lizl Veldsman has won the 2025 Harry M. Vars Award from ASPEN for her innovative ICU study supported by Fresenius Kabi. The study examined the impact of intravenous protein and in-bed cycling on muscle … Read the full press release

Fresenius Kabi Highlights Commitment to Combating Antimicrobial Resistance During AMR Awareness Week

(IN BRIEF) Fresenius Kabi is addressing the global threat of antimicrobial resistance (AMR), which causes millions of deaths annually, through sustainable manufacturing, improved antibiotic access, and promoting responsible use. During AMR Awareness Week, the company highlighted its commitment to reducing … Read the full press release

Fresenius Kabi and Formycon Receive European Approval for Ustekinumab Biosimilar FYB202

(IN BRIEF) Fresenius Kabi, in collaboration with Formycon, has received approval from the European Commission (EC) for FYB202, a biosimilar of ustekinumab (marketed as Stelara® by Johnson & Johnson). This biosimilar is approved for the treatment of serious inflammatory diseases. … Read the full press release

Fresenius Kabi’s Ustekinumab Biosimilar Otulfi® Secures European Approval for Treating Inflammatory Diseases

(IN BRIEF) Fresenius Kabi, in partnership with Formycon AG, has received European Commission approval for Otulfi®, a biosimilar of ustekinumab. This new product, authorized for both subcutaneous and intravenous formulations, will treat inflammatory conditions such as Crohn’s disease, plaque psoriasis, … Read the full press release

Continuity and Strategy: Fresenius Management SE Proactively Extends CFO Sara Hennicken’s Mandate

(IN BRIEF) Fresenius Management SE has extended Sara Hennicken’s term as Chief Financial Officer (CFO) until 2027, two years earlier than planned, to ensure continuity in advancing the #FutureFresenius strategy. Hennicken, who joined Fresenius in 2019, has been instrumental in … Read the full press release

FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release

Fresenius Projects Robust Earnings Growth in 2024 Following Successful 2023

(IN BRIEF) Fresenius had a strong finish in 2023, with a robust fourth quarter performance. They project accelerated earnings growth in 2024 due to the momentum from their #FutureFresenius initiatives. Achieving their raised outlook for FY/23, the company saw continued … Read the full press release