Fresenius Kabi
🇧🇪Belgium
- Country
- 🇧🇪Belgium
- Ownership
- Subsidiary
- Established
- 1999-01-01
- Employees
- -
- Market Cap
- -
Fresenius Kabi Launches Tyenne®, Canada's First Tocilizumab Biosimilar for Autoimmune Conditions
• Fresenius Kabi has commercially launched Tyenne®, the first and only tocilizumab biosimilar available in Canada, offered in both subcutaneous and intravenous formulations.
• Tyenne® is indicated for multiple inflammatory and immune conditions including rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19 treatment.
• The biosimilar provides a cost-effective alternative to the reference biologic Actemra®, expanding access to treatment while being supported by KabiCare®, a comprehensive patient support program.
Fresenius Kabi Launches 30 mg/30 mL Epinephrine Injection for Emergency Care and Septic Shock
• Fresenius Kabi has introduced Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States, expanding its emergency medicine portfolio.
• The new formulation is indicated for emergency treatment of Type 1 allergic reactions including anaphylaxis in both adults and pediatric patients, as well as for increasing blood pressure in adults with septic shock.
• This launch follows Fresenius Kabi's December 2024 introduction of the first generic 1 mg/mL epinephrine vial, reinforcing the company's commitment to domestic pharmaceutical production and essential medicines.
Smart Drug Delivery Systems Market Poised for 17% Growth as Chronic Disease Management Evolves
• The global smart drug delivery systems market reached $12 billion in 2024 and is projected to grow at a CAGR of 17% through 2034, driven by rising chronic disease prevalence and technological advancements.
• Connected inhalers are gaining significant traction for respiratory and neurological conditions, with recent partnerships like Modivcare and Tenovi deploying Adherium's Hailie smart inhalers to improve patient care.
• Injectable smart delivery systems dominated the market with a $7.6 billion valuation in 2024, while North America leads regional adoption with $5.5 billion in revenue, expected to reach $22.2 billion by 2034.
2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars
• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition.
• Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition.
• The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.
Pacira BioSciences Settles EXPAREL Patent Litigation with Fresenius Kabi, Securing Market Exclusivity Until 2030
• Pacira BioSciences has reached a settlement with Fresenius Kabi and other companies regarding patent litigation for its non-opioid pain therapy EXPAREL, allowing limited generic entry beginning in early 2030.
• The agreement permits Fresenius to sell volume-limited amounts of generic bupivacaine liposome injectable suspension starting with high-single-digit percentages, gradually increasing to a maximum in the high thirties by the final years.
• Unlimited generic production by Fresenius will not be permitted until 2039, significantly before EXPAREL's last patent expiration in 2044, allowing Pacira to maintain market dominance for its flagship product.
FDA Approves Avenacy's Propofol Injectable Emulsion as Generic Alternative to Diprivan
• Avenacy has launched FDA-approved Propofol Injectable Emulsion, USP in the United States as a therapeutic generic equivalent to Diprivan for intravenous general anesthesia and sedation.
• The medication is indicated for multiple uses including induction and maintenance of general anesthesia, monitored anesthesia care sedation, and intensive care unit sedation of intubated patients.
• Available in three dosage formats with specialized packaging for medication safety, the product represents Avenacy's 21st launch since October 2023 in a market worth approximately $315 million annually.
Amgen and Fresenius Kabi Reach Settlement in Denosumab Biosimilar Litigation
• Amgen and Fresenius Kabi have settled their BPCIA litigation regarding Fresenius's denosumab biosimilar FKS518, with the New Jersey District Court entering a dismissal order on March 7, 2025.
• This marks Amgen's third denosumab settlement in the past year, following previous agreements with Sandoz in April 2024 and Celltrion in January 2025.
• Two additional denosumab BPCIA cases remain active, with Amgen pursuing litigation against Samsung Bioepis and Accord Biopharma in consolidated proceedings.
Four New Humira Biosimilars Launch in US Market with Steep Discounts up to 85%
• Multiple pharmaceutical companies including Organon, Samsung Bioepis, Sandoz, and Boehringer Ingelheim launched Humira biosimilars in July 2023, offering significant price reductions compared to the original drug.
• Boehringer Ingelheim's Cyltezo becomes the first FDA-approved interchangeable biosimilar to Humira, allowing direct substitution without requiring prescription changes.
• The biosimilar launches come as AbbVie's Humira faces declining sales, with international revenues dropping 25% in Q1 2023 following the drug's $200 billion lifetime sales.
Rheumatoid Arthritis Market Set to Reach $34.7 Billion by 2035, Driven by Novel Therapies and Rising Obesity Rates
• The global rheumatoid arthritis market is projected to grow from $28 billion in 2024 to $34.7 billion by 2035, with a CAGR of 1.97%, fueled by advancements in biologics and targeted therapies.
• Rising obesity rates, sedentary lifestyles, and urbanization are significantly contributing to increased rheumatoid arthritis prevalence, while also reducing the efficacy of some treatments.
• Novel treatment approaches including JAK inhibitors, monoclonal antibodies, and emerging therapies like R-2487 and IMVT-1402 are transforming the treatment landscape with more targeted mechanisms of action.
Formycon Halts Phase III Trial of FYB206 Following FDA Feedback, Faces Market Challenges for Biosimilars
• Formycon terminates Phase III "Lotus" trial for FYB206 biosimilar after FDA confirms therapeutic comparability can be demonstrated through existing melanoma study data and analytical program.
• Company anticipates significant valuation adjustments for FYB202 due to higher-than-expected price discounts in the U.S. biosimilar market, potentially requiring impairment in the high double-digit to low triple-digit million range.
• Commercialization of FYB201/CIMERLI® likely to pause temporarily due to increasing price competition among ranibizumab providers, leading to potential valuation adjustments.
FDA Approves Samsung Bioepis' Denosumab Biosimilars for Bone Health Conditions
• Samsung Bioepis receives FDA approval for OSPOMYV and XBRYK, biosimilar versions of denosumab (Prolia and Xgeva), expanding treatment options for bone health conditions.
• The biosimilars demonstrate comparable efficacy and safety profiles to the reference products, potentially offering more cost-effective alternatives for patients requiring denosumab therapy.
• These approvals mark a significant advancement in expanding access to critical bone health treatments while potentially reducing healthcare costs.
FDA Approves New Vial Sizes of Niktimvo for Chronic Graft-Versus-Host Disease
• The FDA has approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes for chronic graft-versus-host disease (GVHD) after two prior systemic therapies.
• Niktimvo is the first FDA-approved treatment targeting CSF-1R to reduce inflammation and fibrosis in chronic GVHD, offering a novel approach for patients.
• AGAVE-201 trial data showed a 75% response rate at six months with the 0.3 mg/kg dose, demonstrating durable responses across various organs.
• Incyte and Syndax anticipate Niktimvo will be available in early February, with patient support programs to ensure access and financial assistance.
Ibrutinib and Rituximab Combination Shows Promise in Chronic Graft-vs-Host Disease
• Combination therapy with ibrutinib and rituximab is being explored to improve outcomes in chronic graft-vs-host disease (cGVHD).
• Rituximab enhances the therapeutic effects of ibrutinib in treating cGVHD, potentially leading to better patient responses.
• Recent trials have demonstrated promising efficacy and safety data for the ibrutinib and rituximab combination in cGVHD.
• Clinical practice may shift towards incorporating this combination to optimize treatment strategies for cGVHD patients.
Otulfi (Ustekinumab) Biosimilar Gains Regulatory Approvals in Canada and the UK for Inflammatory Diseases
• Health Canada approved Otulfi, a ustekinumab biosimilar, for subcutaneous and intravenous use in treating Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis.
• The UK's MHRA also approved Otulfi for the same indications, following approvals in the US and Europe, expanding treatment options for inflammatory diseases.
• Otulfi, developed by Formycon and commercialized by Fresenius Kabi, targets interleukin-12 and interleukin-23, offering a cost-effective alternative to Stelara.
• These approvals underscore the commitment to increasing access to biosimilars, potentially reducing healthcare costs and improving patient access to essential medicines.
FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara
• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions.
• Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications.
• These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.
First RoActemra Biosimilar Tyenne Receives EU Approval, Marking Milestone for Fresenius Kabi
• The European Commission has granted approval for Tyenne, the first biosimilar version of Roche's blockbuster drug RoActemra (tocilizumab), developed by Fresenius Kabi for multiple inflammatory conditions and severe COVID-19.
• Tyenne is approved for all RoActemra indications, including rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome, representing a significant advancement in accessible treatment options.
• This approval marks Fresenius Kabi's third biosimilar success and aligns with their Vision 2026 strategy to generate €1 billion in additional revenue every three years.
© Copyright 2025. All Rights Reserved by MedPath