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Fresenius Kabi issues nationwide recall of Tyenne(R)(tocilizumab-aazg) Injection 400 mg/20 mL vials Due to Presence of Glass Particles. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Summary. * Company Announcement Date: - August 10, 2026 * FDA Publish Date: - August 11, 2026 * Product Type: - Drugs * Reason for Announcement: - Due to Presence of Glass Particles * Company Name: - Fresenius Kabi * Brand Name: - Fresenius Kabi * Product Description: - Tyenne Injection 400 mg/20 mL vial Company Announcement. August 10, 2026 - LAKE ZURICH, Ill. - Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne(R)(tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles. Risk Statement:The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins. More seriously, glass particles can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Tyenne(R)(tocilizumab-aazg) Injection is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); adult patients with giant cell arteritis; patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis; patients 2 years of age and older with active systemic juvenile idiopathic arthritis; adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and certain hospitalized adult patients with COVID-19. Recalled product can be identified as follows (with label below): | Product Name/Size | NDC Number | Product Code | Lot Number | Expiration Date | First Ship Date | Last Ship Date | | Tyenne(R)(tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial | 65219-594-20 | 590120 | 16UI07 | 08/2028 | 03/03/2026 | 03/25/2026 | Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL was distributed nationwide to wholesalers, distributors and direct customers. Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they are to immediately discontinue distributing, dispensing, or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall. Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time or send an e-mail to either [email protected] or [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. * Complete and submit the report Online: www.fda.gov/medwatch/report.htm * Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Company contact information. * Media: - Matt Kuhn - (847) 220-3033

Fresenius Kabi advances global biosimilars portfolio with FDA, EMA review of vedolizumab candidate and U.S. Approval of rituximab biosimilar. Fresenius Kabi's vedolizumab biosimilar PB016 enters FDA and EMA review, while its rituximab biosimilar gains U.S. FDA approval, expanding access to biologics. Fresenius Kabi has achieved two important regulatory milestones within days, strengthening its global biosimilars portfolio across autoimmune diseases and oncology. The company announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory applications for review of PB016, its proposed intravenous (IV) vedolizumab biosimilar referencing Entyvio(R)(vedolizumab). Shortly thereafter, the FDA approved the company's rituximab biosimilar for the U.S. market, further expanding its biosimilar offerings in immunology and oncology. FDA and EMA Accept PB016 for Regulatory Review. The FDA accepted Fresenius Kabi's Biologics License Application (BLA), while the EMA validated the Marketing Authorisation Application (MAA) for PB016. The proposed biosimilar is being developed by Polpharma Biologics, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa, subject to regulatory approval. The regulatory submissions are supported by a comprehensive biosimilar development program designed to demonstrate that PB016 is highly similar to the reference product through analytical, non-clinical, pharmacokinetic, and clinical evaluations, consistent with global biosimilar approval requirements. Clinical program supports biosimilarity. The clinical evidence for PB016 includes a Phase 1 study in healthy volunteers and a Phase 3 clinical trial (NCT05771155) in patients with moderately to severely active ulcerative colitis. Together, these studies contribute to the totality of evidence required to establish biosimilarity to the reference biologic. Vedolizumab is a gut-selective monoclonal antibody that targets the α4β7 integrin, preventing inflammatory lymphocytes from migrating into gastrointestinal tissue. It is approved for adults with moderately to severely active ulcerative colitis and Crohn's disease, two chronic forms of inflammatory bowel disease (IBD) that affect an estimated 2.4 million people in the United States and approximately 2.5 to 3 million people across Europe. If approved, PB016 could expand treatment options and improve access to biologic therapy for patients living with IBD by providing a high-quality, lower-cost alternative to the reference product. FDA approves rituximab biosimilar for the U.S. Building on the momentum of the vedolizumab regulatory submissions, Fresenius Kabi also announced FDA approval of its rituximab biosimilar, developed by Dr. Reddy's Laboratories as a biosimilar to Rituxan(R)(rituximab). Under an exclusive commercialization agreement, Dr. Reddy's developed, manufactured, and submitted the product, while Fresenius Kabi holds exclusive U.S. commercialization rights. Rituximab is a CD20-directed monoclonal antibody indicated for multiple hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). The FDA approval was based on the totality of evidence demonstrating high similarity to the reference product, with no clinically meaningful differences in quality, safety, or efficacy. Strengthening the biosimilars portfolio. Together, the regulatory review of PB016 and the FDA approval of the rituximab biosimilar represent important advances in Fresenius Kabi's FutureFresenius strategy, which identifies biopharmaceuticals as a key growth area. The two milestones strengthen the company's presence in both autoimmune diseases and oncology while reinforcing its integrated capabilities across biosimilar development, manufacturing, and global commercialization. As biosimilars continue to improve patient access to biologic medicines, these regulatory achievements position Fresenius Kabi to further expand its global portfolio of high-quality, affordable treatment options for patients with chronic inflammatory diseases and cancer. Reference. About the writer. Kirti Kumbhar (LinkedIn) is an MPharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.

Fresenius Kabi and Polpharma submit aBLA for Proposed Entyvio(R)(vedolizumab) biosimilar PB016. On July 31, 2026, Fresenius Kabi and Polpharma announced the FDA acceptance of their aBLA for PB016 (vedolizumab), a proposed intravenous biosimilar of Takeda's Entyvio(R)(vedolizumab). They also announced the acceptance of their Marketing Authorisation Application (MAA) by the EMA for PB016. This is the second publicly announced aBLA for an Entyvio(R) biosimilar, following Alvotech's announcement of its aBLA for AVT16 in June 2026 (previously reported Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio(R) Biosimilar - AVT16). Currently, there are no pending patent disputes related to Entyvio(R) biosimilars, and no patents are listed in the Purple Book for Entyvio(R). Takeda reported FY2025 (Apr. 1, 2025 - Mar. 31, 2026) U.S. sales of JPY 623.7 billion (approximately $3.89 billion USD) for Entyvio(R). The author would like to thank April Breyer Menon for her contributions to this article.