Key Development
A reference market worth an estimated $5.7 billion is being targeted by a biosimilar still in early-stage development. The more important signal, however, is not market size. It is molecular and commercial complexity.
On September 18, 2026, mAbxience and Sandoz entered into a licensing, development, manufacturing and commercialization agreement covering a proposed biosimilar to emicizumab, the active ingredient in Roche’s Hemlibra for haemophilia A. mAbxience will lead development and manufacturing through GMP-approved facilities in Spain and Argentina. Sandoz will hold exclusive global commercialization rights, except in Argentina, Uruguay and Paraguay. Financial terms remain confidential.
The candidate remains in early-stage development. If successfully developed, emicizumab would become the first haemophilia biosimilar in Sandoz’s pipeline and expand that pipeline to approximately 40 assets. The agreement follows other portfolio-building deals with Henlius and Samsung Bioepis.
What makes the target particularly attractive is that the originator franchise is still expanding. Hemlibra generated CHF4.754 billion in 2025 sales, up 11% at constant exchange rates. Sales reached CHF2.492 billion in the first half of 2026, again growing 11%.
Why It Matters
- Biosimilars are moving into more complex biology. Emicizumab is a bispecific antibody that bridges activated factor IX and factor X to restore effective haemostatic activity. Replicating such a product requires sophisticated analytical and manufacturing capability.
- Rare disease is becoming a biosimilar battleground. This is Sandoz’s first proposed haemophilia biosimilar, extending a market historically concentrated in oncology, immunology and other larger biologic categories.
- Partnerships can separate technical and commercial risk. mAbxience contributes development and manufacturing infrastructure; Sandoz contributes regulatory reach and global commercialization. Neither company needs to build the entire value chain independently.
- Payers gain another potential price lever. Hemlibra is approved in more than 100 countries and offers subcutaneous prophylaxis once weekly, every two weeks or every four weeks. A successful biosimilar could introduce meaningful procurement competition in a high-cost specialty category.
Healthcare Insight Analysis
Healthcare Insight’s central view is that this agreement signals a shift from biosimilar scale toward biosimilar sophistication.
The first large waves of biosimilar development were concentrated around biologics with broad patient populations and established commercial pathways — oncology monoclonal antibodies, autoimmune therapies and supportive-care products.
Emicizumab raises the bar.
It targets a rare genetic condition, uses a bispecific antibody architecture and competes against an originator that is still growing at double-digit rates. That creates a different risk-return profile from entering a mature, declining biologic category.
Technical comparability is only part of the challenge. A future emicizumab biosimilar will also need to earn confidence from regulators, haematologists and patients in a therapeutic area where successful bleed prevention has substantial clinical consequences.
Hemlibra’s current value proposition makes that hurdle particularly important. The therapy can be administered subcutaneously at intervals of up to four weeks. In the FDA-reviewed HAVEN 3 study, approved regimens reduced annualized treated bleed rates by 96% and 97% compared with no prophylaxis in the relevant population.
That creates an unusual dynamic. Payers may have a powerful incentive to introduce competition, while physicians and patients have an equally understandable incentive to avoid disrupting a regimen that is working effectively.
In rare-disease biosimilars, trust may therefore matter almost as much as discount.
The Sandoz model is also strategically revealing. The company has 13 marketed biosimilar molecules across nearly 100 countries, while its development pipeline has expanded to around 40 assets. Rather than internalizing every stage, it is increasingly combining its commercial infrastructure with external development and manufacturing platforms.
This resembles a global biosimilar portfolio-aggregation strategy: identify technically credible assets, secure rights, and use global regulatory and commercial scale to monetize them across many markets.
For mAbxience, the economics are complementary. The company can monetize sophisticated biologics-development and manufacturing capacity without independently building a Sandoz-sized commercial organization in every geography.
Market Implications
Sandoz: gains exposure to a large, high-value rare-disease franchise, but development and regulatory risks remain substantial because the candidate is still early-stage.
mAbxience and CDMOs: the partnership increases the strategic value of complex-biologics manufacturing platforms. Success could strengthen mAbxience’s ability to attract additional global partnerships.
Roche: future biosimilar pressure is becoming more visible, although Hemlibra remains a growing franchise today. Physician loyalty, accumulated evidence and lifecycle strategy will influence the eventual erosion curve.
Payers and providers: a biosimilar could create new negotiating leverage, but procurement decisions will need to balance savings with treatment continuity and clinician confidence.
Two signals matter next: whether the candidate successfully progresses through analytical and clinical development, and how aggressively Sandoz ultimately prices the product relative to Hemlibra if commercialization is reached.
If the program succeeds, the implication extends beyond haemophilia: biosimilars will no longer be competing only for yesterday’s mature blockbusters. They will increasingly target some of pharma’s most specialized, technically demanding and valuable biologic franchises.