Sandoz and mAbxience Target Hemlibra's $5.7B Market with New Biosimilar Pact

MADRID – September 18, 2026 — For years, the biosimilar industry has feasted on the low-hanging fruit of blockbuster oncology and immunology biologics. But as the market for first- and second-wave biosimilars becomes increasingly crowded and commoditized, the frontier is shifting toward a much more complex and lucrative domain: rare diseases. Today, that shift was crystallized as Sandoz and mAbxience announced a global licensing, development, manufacturing, and commercialization agreement for a proposed biosimilar candidate referencing Hemlibra (emicizumab).

The Biosimilar Wave Reaches Rare Diseases

Hemlibra, Roche’s blockbuster therapy for hemophilia A, represents a staggering $5.7 billion global reference market. Hemophilia A, a rare genetic disorder caused by insufficient or defective factor VIII, accounts for roughly 80 percent of all hemophilia cases worldwide. While the reference biologic revolutionized treatment by offering a highly effective subcutaneous prophylaxis, its price tag—often running between $450,000 and $500,000 annually per patient in the United States—has placed a heavy burden on global healthcare budgets.

By targeting this exact pressure point, the newly announced partnership aims to democratize access to life-altering hematology treatments while capturing a slice of a highly defensible market. The World Health Organization's recent addition of emicizumab to its Model List of Essential Medicines underscores the urgent global demand for more affordable alternatives. For industry observers tracking the early innings of this market transformation, the pivot from retail immunology to complex hospital specialty care represents the necessary evolution of the biosimilar business model.

A Strategic Division of Labor

The architecture of this agreement highlights a growing trend in biopharmaceutical corporate strategy: the pairing of specialized contract development and manufacturing organizations (CDMOs) with commercial heavyweights. Under the terms of the deal, mAbxience will spearhead the technical development, scale-up, and manufacturing of the biosimilar across its state-of-the-art, GMP-approved facilities in Spain and Argentina. Sandoz, leveraging its formidable standalone infrastructure following its separation from Novartis, secures exclusive worldwide commercialization rights.

Notably, the agreement carves out Argentina, Uruguay, and Paraguay. This regional exclusion is a strategic nod to mAbxience’s corporate lineage. Founded by the Insud Pharma group and now majority-owned by Fresenius Kabi—following a €495 million acquisition in 2022—the biomanufacturer retains direct, high-margin commercial relationships in its domestic base of the Southern Cone. Sandoz, meanwhile, adds a crown jewel to a rapidly expanding pipeline that now boasts 40 disclosed assets, further validating its aggressive post-spin-off "in-license and out-commercialize" playbook.

"This agreement with Sandoz represents a significant recognition of mAbxience's development and manufacturing platform and the expertise of our teams," said Jurgen Van Broeck, Chief Executive Officer of mAbxience. "This agreement combines our capabilities with Sandoz's global biosimilars reach and provides a clear pathway to broaden access to treatment for patients living with hemophilia A. It also reinforces our strategy of combining world-class development and manufacturing capabilities with selected commercial partnerships."

Navigating the Bispecific Bottleneck

Developing an emicizumab biosimilar is vastly more complex than reverse-engineering standard monoclonal antibodies like Humira or Herceptin. Emicizumab is a bispecific antibody—an asymmetric coagulation mimic engineered to bridge activated coagulation factor IX with factor X, effectively replacing the missing factor VIII protein.

To express this in host cells, two distinct heavy chains and a common light chain must assemble perfectly. Without meticulous engineering, cells can produce inactive, mispaired by-products. Innovators historically utilized proprietary "knobs-into-holes" technology to force the correct heterodimeric assembly. Biosimilar developers must now replicate this precise structural architecture without infringing on secondary process patents, requiring high-order analytical rigor, advanced mass spectrometry, and complex functional potency assays.

This extreme technical barrier is a feature, not a bug, for early movers. Industry analysts note that while the adalimumab market saw up to a dozen biosimilar entrants rapidly compress margins, the emicizumab arena is likely to host only a handful of global competitors at launch. While China's CSPC Pharmaceutical Group recently received investigational new drug clearance to initiate Phase 1 trials for its candidate, the broader global pipeline remains sparse. By locking in mAbxience’s specialized bioprocessing capabilities now, Sandoz effectively secures its position in a high-barrier market insulated from the hyper-commoditization seen elsewhere.

Patent Thickets and the Road to 2030

The timing of this collaboration is far from coincidental. While emicizumab was first approved by the FDA in late 2017, its exclusivity protections are layered across orphan drug designations, regulatory data protection, and a dense thicket of patents.

In the United States, statutory 12-year reference product exclusivity under the Biologics Price Competition and Innovation Act (BPCIA) shields the drug from biosimilar licensing until November 2029. Furthermore, primary composition-of-matter patents, bolstered by patent term extensions, are projected to provide a protective runway into 2032 across the US, Europe, and Japan.

The originator companies are not sitting idle as this patent cliff approaches. Innovators are actively building clinical defenses, advancing next-generation therapies designed to capture market share before biosimilars can launch. Novel treatments, such as once-monthly factor VIII mimetic bispecific antibodies and siRNA therapies targeting antithrombin, are currently advancing through late-stage clinical trials. Gene therapies also continue to loom on the horizon, offering the promise of sustained endogenous factor expression, though their commercial uptake has thus far been constrained by high upfront costs and variable durability.

Despite these evolving competitive dynamics, the fundamental demand for a cost-effective, highly efficacious prophylaxis remains robust. By initiating this co-development pact in 2026, Sandoz and its manufacturing partner are perfectly synchronizing their efforts with the standard six- to seven-year timeline required to push a complex biosimilar through preclinical characterization, clinical bioequivalence trials, and regulatory submission. When the global patent cliff finally materializes at the dawn of the next decade, this alliance will be fully positioned to intercept a multi-billion-dollar market transition, offering a critical financial relief valve for healthcare systems and a new standard of accessible care for hemophilia patients worldwide.