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Fresenius Kabi manufacturing plant hit with FDA warning letter after adverse events. October 1, 2026 | Patients had adverse events after receiving a Fresenius Kabi medicine that experienced manufacturing deviations. The FDA has accused Fresenius Kabi of failing to sufficiently investigate a critical manufacturing deviation linked to reports of adverse events. FDA inspectors spent three weeks at Fresenius Kabi's manufacturing facility in Melrose Park, Illinois, earlier this year. The investigators found fault with Fresenius Kabi's response to reports of adverse events in patients injected with famotidine, an H2 blocker used to treat heartburn and stomach ulcers, the FDA explained in a warning letter published Tuesday. The reports included apparent pyrogenic reactions, a medical term for fever. Pyrogen contamination to injectable drug products can lead to significant adverse events such as fever, hypotension, inflammatory reactions, anaphylactic shock or death, the FDA told Fresenius Kabi. The company's famotidine injection manufacturing surpassed multiple bioburden action limits, the FDA said. The agency found Fresenius Kabi "failed to sufficiently investigate this critical deviation and permitted batch release following passing finished drug product test results." Subsequent testing in response to the adverse events revealed an endotoxin failure and triggered a recall of three famotidine batches. No patient safety concerns have been identified, a Fresenius Kabi spokesperson told BioSpace via email. The spokesperson said the facility "remains operational, and at this time we do not anticipate significant disruptions to the supply of products currently on the market," adding that the company "is taking the necessary actions to address [the FDA's observations] thoroughly and responsibly." The FDA deemed Fresenius Kabi's initial response inadequate. Replying in March to the FDA's Form 483, the company acknowledged that bioburden samples showed Gram-negative confluent growth, indicating that a lawn of bacteria covered the surface of the test medium. Fresenius Kabi did not consider the excessive bioburden, meaning the number of bacteria, an elevated endotoxin risk, the FDA said. Endotoxins are parts of bacteria that can activate the immune system, causing adverse events. While Fresenius Kabi vowed to enhance endotoxin sampling and testing, the FDA called out the company for failing to commit to a comprehensive review of its complaint system to increase vigilance. The FDA wants Fresenius Kabi to maintain ongoing, robust upstream control, adding that "any batch testing that reveals atypical bioburden levels is a signal that necessitates prompt attention." The FDA also criticized Fresenius Kabi's handling of media fill failures and the discovery of hair in drug products. Fresenius Kabi determined that operators' deficient aseptic techniques could have contributed to media fill failures. The company's investigations "did not consider how the poor aseptic practices went undetected by your firm's aseptic observer program during commercial operations," the FDA said. FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly's tirzepatide and Novo's semaglutide "regularly or in inordinate amounts" at a site with "insanitary conditions." September 24, 2026 Starting in May 2022, Fresenius Kabi documented at least nine cases of extrinsic contamination during its visible particulate inspection. The FDA named hair as an example of an extrinsic contaminant. "This contamination was described as free-floating and in direct contact with the drug product," the FDA said. "Drug products contaminated with hair can have microbial contamination and are generally considered adulterated. You did not initiate timely investigations in response to this contamination." The FDA, which sent the warning letter on Sept. 22, gave Fresenius Kabi 15 business days to respond. Remediations are underway at the site, the spokesperson said. Nick is a freelance writer who has been reporting on the global life sciences industry since 2008.

Fresenius completes acquisition of mAbxience, creating a stronger platform for future portfolio expansion. Oct 01, 2026, 01:00 ET * The transaction builds on the successful partnership between Fresenius and mAbxience established in 2022. * Full ownership creates a stronger platform to enhance quality and supply resilience, while supporting future innovation and broader patient access to high-quality biosimilars. * mAbxience will continue supporting its existing customers and remains fully committed to maintaining quality and reliable supply of its biosimilars. MADRID, Oct. 1, 2026 /PRNewswire/ - mAbxience today announced that Fresenius SE & Co. KGaA has acquired the remaining 45% of mAbxience from Insud Pharma, building on the successful partnership established between the two companies in 2022 and marking the beginning of a new phase of growth for the company. Fresenius acquired a 55% majority stake in mAbxience in August 2022 and has consolidated the business since then. Full ownership completes that structure: mAbxience biosimilars platform is now wholly owned within Fresenius Kabi's Biopharma business, which covers the full value chain from development and manufacturing through to commercialization. The acquisition builds on a successful partnership that has already delivered important development, manufacturing, technology-transfer and regulatory milestones. This collaboration has contributed to the expansion of manufacturing capabilities, the advancement of technology transfer programs and the strengthening of mAbxience's position as a global biopharmaceutical company. Bringing the organizations together under full ownership creates a stronger platform to enhance quality and supply resilience, while supporting future innovation and broader patient access to high-quality biosimilars at a time when a large wave of biologics is losing exclusivity. Michael Sen, Chief Executive Officer of Fresenius, said: "Completing the acquisition of mAbxience marks the next milestone in building a leading, vertically integrated biopharma business at scale. When we first invested in mAbxience four years ago, the market opportunity was promising but still evolving. Our initial majority stake gave us access to a highly competitive platform while managing risk. Since then, the market has developed strongly, mAbxience has delivered, and Fresenius now has the financial strength to take this next step. Full ownership gives us complete control over cost, capacity and launch timing, and full economic benefit, as the next wave of biologics loses exclusivity. For patients, that means dependable access to high-quality biosimilars; for shareholders, it is a disciplined investment in a business we know well." Jurgen van Broeck, Chief Executive Officer of mAbxience, said: "mAbxience was founded to serve patients, while proving that world-class biologics could be developed and manufactured at a cost the world could afford. Since 2022, our partnership with Fresenius has demonstrated the strength of combining our people, expertise and capabilities. I would also like to recognize and thank Insud Pharma for its support and commitment over the past decade. The success of mAbxience today is built on the vision, dedication and hard work of many people who have contributed to this journey from the very beginning. Full ownership is the natural next step and creates an even stronger platform for innovation, growth and long-term impact for patients, customers, and partners. As we begin this next chapter together, we will continue to build on the entrepreneurial spirit, scientific expertise and commitment to patients that have driven mAbxience's success." mAbxience will continue to support its existing customers and partners, and the company remains fully committed to maintaining quality, reliable supply and the delivery of its ongoing commitments worldwide. Jurgen Van Broeck, Chief Executive Officer of mAbxience, will continue to lead the business, reporting to Dr. Sang-Jin Pak, President Biopharma at Fresenius. SOURCE mAbxience

Does the direct-to-employer route for biosimilars make sense? Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option. Waltz Health, a digital health company, has announced that it has agreed to team with Fresenius Kabi to help supply its three biosimilars in a direct-to-employer arrangement through its existing Waltz Connect platform. First reported by Fierce Healthcare, the biosimilars that will be available direct-to-employer will be Fresenius Kabi's Idacio (adalimumab), Tyenne (tocilizumab), and Otufli (ustekinumab). Waltz Health already has direct-to-employer arrangements with Eli Lilly and Novo Nordisk for their GLP-1 products. By using Waltz Connect, corporate members can avoid traditional wholesaler and pharmacy benefit manager arrangements (and thus avoid rebate contracts). As the products are still delivered through specialty pharmacies, the typical provider and patient supports can still be provided. The direct-to-employer benefit for biosimilars. This channel would appear to assure that patients directly benefit from discounts received by the corporate employer. In Fierce Healthcare, Fresenius Kabi's President of Biopharma Sang-Jin Pak, MD, stated, "As we continue to expand our biosimilars portfolio, we remain focused on innovative partnerships that help employers and payers access high-quality treatment options." Employer benefit consultant F. Randy Vogenberg, PhD, told BR&R, "Making the costly drug purchase experience easier and engaging for the consumer as patient remains important. Leveraging biosimilar solutions could further the value to employers and their plan beneficiaries (patients) as other market forces change coverage affecting access to treatment options." Dr. Vogenberg, Principal, FRV Health Strategy Advisory, Greenville, SC, said, "Addressing economic coverage gaps can be a win-win short-term solution for multiple stakeholders." Assuming that the employers signing onto Waltz Health have access to the same pricing for biosimilars as PBMs and others do, this seems a natural option. In surveys, employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. In other biosimilar news. Teva Pharmaceuticals received its second FDA approval for its denosumab biosimilar. After receiving its approval for Ponlimsi in March, referencing Prolia, to prevent osteoporosis, Degevma, referencing Xgeva, will be prescribed to prevent skeletal-related complications in patients with multiple myeloma or bone metastases. Teva plans to launch both products "in the coming months." It joins a crowded field of 9 manufacturers with both denosumab indications. Meitheal Pharmaceuticals announced September 28 that the FDA approved its high-concentration formulation of Yusimry, the company's adalimumab biosimilar. The company will now be able to compete for prescriptions for this most-used adalimumab biosimilar formulation. "With this approval, we now have FDA approval for both low- and high-concentration formulations of Yusimry, marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases," said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. In July, the company had also received FDA approval for its insulin aspart biosimilar Garzulys, which is produced by Emerge Bioscience. Meitheal has marketing responsibility for this agent. This article was written by its Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry's original, comprehensive and updated database of biosimilar filings with the FDA.