FORT LEE, N.J., October 9, 2025 — Kedrion Biopharma today announced the U.S. commercial launch of YIMMUGO® (Immune Globulin Intravenous, Human-dira, 10%), following FDA approval on June 13, 2024. The launch marks a major expansion of Kedrion’s U.S. plasma-derived therapy portfolio and strengthens the company’s role in addressing the growing global demand for safe, effective immunoglobulin (Ig) treatments for Primary Immunodeficiency (PI). Developed by Biotest AG, a company within the Grifols Group, YIMMUGO® is a modern, highly purified 10% IVIG formulation indicated for adults and children ≥ 2 years with PI. Under an exclusive commercialization agreement, Kedrion Biopharma will distribute and market YIMMUGO® across the United States, supported by CuraScript SD by Evernorth as its exclusive distribution partner.
Science Significance
YIMMUGO® represents a scientific evolution in intravenous immunoglobulin design.
Engineered via Biotest’s Next Level production platform, the therapy features optimized protein integrity and reduced infusion-related risk. Importantly, YIMMUGO® is free of sucrose, a stabilizer associated with renal dysfunction in older IVIG products—enhancing both tolerability and patient safety. Primary Immunodeficiency encompasses more than 550 rare disorders in which the immune system fails to produce adequate antibodies. For this population, IVIG infusions remain the therapeutic standard, compensating for missing immune protection. The introduction of YIMMUGO® brings a next-generation, plasma-purified immunoglobulin that advances both product purity and consistency, reaffirming plasma science as an essential domain of biologic innovation. By combining process efficiency with patient-centric formulation, Kedrion and Biotest signal a continued investment in precision plasma therapeutics, where incremental manufacturing improvements yield measurable clinical benefits.
Regulatory Significance
FDA approval of YIMMUGO® in 2024 validated Biotest’s Next Level manufacturing facility and reinforced international regulatory collaboration between the FDA and European authorities. The approval aligns with global cGMP and cGxP quality standards, underscoring Kedrion’s reliability as a global plasma partner. Like all IVIG therapies, YIMMUGO® carries a boxed warning for potential thrombosis, renal dysfunction, and acute renal failure—key safety class effects—yet its sucrose-free formulation mitigates the major risk factors identified in prior generations of IGIV products. This regulatory milestone also demonstrates the FDA’s ongoing support for diversifying the U.S. plasma therapy supply chain, a crucial step in preventing shortages and ensuring national biologics resilience.
Business Significance
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YIMMUGO®’s launch marks a strategic pivot for Kedrion Biopharma, positioning the company for accelerated growth in the competitive U.S. IVIG segment. The company’s exclusive U.S. commercialization rights reflect its strengthened alliance with Biotest AG and its parent, Grifols, combining European biologics innovation with American market reach. We are implementing a bold and patient-centric strategy to expand and differentiate our Ig portfolio,” said Bob Rossilli, Chief Commercial Officer and U.S. General Manager of Kedrion Biopharma. “Our experience, agility, and commitment to patients position us to make a meaningful impact in the IVIG sector. The U.S. IVIG market continues to expand, driven by rising PI diagnosis rates, aging populations, and heightened awareness of immune health. By adding YIMMUGO® to its portfolio, Kedrion enhances its market differentiation and revenue diversification, complementing its core strengths in coagulation, neurological, and immune-deficiency therapies.
Patients’ Significance
For people living with Primary Immunodeficiency, YIMMUGO® delivers a modern, accessible, and well-tolerated therapy designed to restore immune balance and reduce infection-related morbidity. Roughly 500,000 Americans and over 6 million people globally live with PI, though many remain undiagnosed or misdiagnosed. These patients often face barriers to consistent therapy access—limited supply, reimbursement delays, and inconsistent product availability. Kedrion’s structured specialty-pharmacy distribution model, led by CuraScript SD, addresses these barriers head-on, offering reliable logistics, high-touch patient support, and coordinated physician engagement. This approach not only improves access but reinforces the company’s patient-first philosophy: every vial delivered supports a patient’s stability, independence, and daily life.
Policy Significance
The introduction of YIMMUGO® also aligns with U.S. public-health policy priorities emphasizing biologics security, supply-chain resilience, and rare-disease access. Kedrion operates 68 plasma collection centers in the U.S., alongside global manufacturing facilities across five countries—supporting the national goal of self-sufficiency in plasma-derived therapies. Through its vertically integrated model—spanning plasma collection, fractionation, manufacturing, and distribution—Kedrion contributes to global regulatory harmonization and ensures consistent pharmacovigilance oversight in line with cGxP principles. YIMMUGO®’s commercialization demonstrates how private-sector innovation can reinforce public-sector health objectives: securing safe, high-quality biologics for vulnerable populations while promoting sustainability in plasma resource management.
Transaction Highlights
The launch of YIMMUGO® (Immune Globulin Intravenous, Human-dira, 10%) in the United States marks a significant commercial and strategic milestone for Kedrion Biopharma, expanding its presence in the global immunoglobulin therapy market. Originally introduced in Europe in 2022 and granted U.S. FDA approval on June 13, 2024, YIMMUGO® becomes the first U.S. product from Biotest AG’s Next Level production facility, distributed exclusively through CuraScript SD by Evernorth. Under an exclusive licensing agreement, Kedrion Biopharma holds the sole U.S. commercialization rights, reinforcing its leadership in the treatment of rare and chronic immune disorders. This collaboration strengthens Kedrion’s growing immunology and rare disease portfolio and establishes a foundation for future plasma-derived therapy introductions in the U.S. market. With this launch, Kedrion extends its patient-centric strategy, addressing the rising demand for advanced intravenous immunoglobulin (IVIG) options and enhancing access for patients living with Primary Immunodeficiency (PI) through a dedicated specialty distribution network.
Source: Kedrion Biopharma Press Release
