mAbxience and Sandoz have signed a global collaboration agreement to develop and commercialize a biosimilar candidate of emicizumab, targeting the haemophilia A market valued at $5.7 billion.
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MARKET ACCESS · BIOSIMILARS RARE DISEASE · SEPTEMBER 26, 2026 · GLOBAL
A $5.7 billion reference market now faces a biosimilar candidate backed by a global partner. mAbxience, the biosimilar developer and manufacturer majority-owned by Fresenius SE & Co. KGaA and partially by Insud Pharma, has signed a global collaboration agreement with Sandoz, the Swiss generics and biosimilars specialist, to develop and commercialize a biosimilar candidate of emicizumab — the bispecific antibody used to prevent bleeding episodes in people with haemophilia A, according to the company's announcement of September 18, 2026.
The $5.7 billion figure represents the estimated global value of the emicizumab reference market, per mAbxience's official statement. That is the revenue base now in the crosshairs of a deal that divides responsibilities along the lines that have become standard in biosimilar licensing: mAbxience retains development and manufacturing, while Sandoz assumes commercialization worldwide. mAbxience retains commercial rights for Argentina, Uruguay, and Paraguay.
Sandoz's Pipeline Logic and the Haematology Gap
The agreement fits a pattern Sandoz has been executing with increasing speed. At its capital markets day in September 2026, the company disclosed plans to expand its biosimilars portfolio from 13 drugs currently to more than 100 by 2040. In August 2026, Sandoz agreed to pay up to $322 million, with up to $100.5 million expected to be invoiced in 2026, to Shanghai Henlius, a Chinese biopharmaceutical company, for an initial three biosimilar candidates — targeting evolocumab, belimumab, and cetuximab — within a collaboration covering up to 10 assets, per AllSci. The mAbxience deal extends that in-licensing logic into haematology, a therapeutic area where originator pricing has historically faced less biosimilar competition than oncology or immunology.
The commercial upside of any global biosimilar agreement remains contingent on market-access dynamics — rebate structures, formulary placement, and payer contracting — particularly in the United States. The emicizumab biosimilar candidate's timeline to those markets has not been publicly disclosed.
mAbxience's Manufacturing Base and Partnership Track Record
mAbxience will develop and manufacture the candidate at its facilities in Spain and Argentina, according to the company's announcement.
The Sandoz agreement is not mAbxience's first partnership of this structure. In April 2024, Teva Pharmaceutical, the Israeli-American drugmaker, signed an in-licensing accord with mAbxience covering an investigational oncology biosimilar, according to Teva. In November 2024, mAbxience and Egis Pharmaceutical PLC, a Hungarian drug company, announced a licensing agreement for two biosimilar candidates across Central and Eastern European markets, according to mAbxience.
The accumulation of these agreements — Teva for oncology, Egis for Central and Eastern Europe, and now Sandoz for a rare-disease biologic — suggests mAbxience is operating as a platform manufacturer that monetises its development and production capabilities through commercial partners rather than building its own global sales infrastructure. Whether that model generates sufficient returns relative to the capital deployed in manufacturing is a question the company has not addressed in public disclosures.
The principal friction point for the emicizumab biosimilar candidate is not manufacturing capacity but regulatory and clinical complexity. Emicizumab is a bispecific antibody — a structurally more complex molecule than conventional monoclonal antibodies — and biosimilarity demonstration for such compounds typically requires more extensive analytical and clinical data packages than conventional monoclonals. Without those anchors, the commercial value of the agreement remains difficult to size independently.
On the competitive landscape, the originator product is marketed by Roche; no approved emicizumab biosimilar was identified in the sources reviewed. No analyst estimate of peak biosimilar sales for this candidate has been published in available sources. The $5.7 billion reference-market figure traces to mAbxience's own statement; an independent corroboration was not available at the time of writing.
What to Watch
- Disclosure of the emicizumab biosimilar candidate's development stage and any regulatory submissions filed with the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), or the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil's health surveillance agency
- Whether Sandoz's September 2026 capital markets day targets are revised in light of the pace of in-licensing activity
- Originator response: any Roche pricing adjustment or patient-support programme modification in markets where the biosimilar candidate advances toward approval
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The deeper signal in this agreement is structural: haemophilia A, a condition historically served by a small number of high-cost biologics with limited price competition, is entering the biosimilar era later than oncology or immunology — but the entry, when it comes, will arrive with a global distribution partner already in place. The lag between announcement and commercial reality in biosimilars is typically measured in years, not quarters; the clock on that lag started with this deal.
Market Context
$5.7B
Emicizumab reference market, estimated global value
13 to 100+
Sandoz biosimilars portfolio: current vs. 2040 target
Sources: mAbxience official statement (2026-09-18); Sandoz Capital Markets Day (September 2026)
Why this is relevant
Patients
A biosimilar candidate for emicizumab, used to prevent bleeding in people with haemophilia A, has entered global development under a mAbxience-Sandoz collaboration. If approved, it could introduce price competition into a segment where no approved biosimilar was identified, potentially broadening access — though the development timeline and regulatory pathway have not been publicly disclosed.
Industry
The agreement extends mAbxience's platform-manufacturing model into haematology, pairing its production capacity in Spain and Argentina with Sandoz's global distribution network. Sandoz, which targets more than 100 biosimilars by 2040 from 13 currently, appears to be using in-licensing — including a deal worth up to $322 million with Shanghai Henlius in August 2026 — as a mechanism to fill pipeline gaps faster than internal development allows.
Payers
The emicizumab reference market is valued at $5.7 billion globally, per mAbxience. Whether haematology biosimilars achieve the rapid uptake seen in some oncology markets will depend on formulary decisions and contracting structures in each market, none of which have been specified in the announcement.
Litigation
Emicizumab is a bispecific antibody, structurally more complex than conventional monoclonal antibodies, and biosimilarity demonstration for such compounds typically requires more extensive analytical and clinical data packages.
Sources: mAbxience · Sandoz · Pharma Manufacturing · AllSci · Teva (April 2024) · mAbxience (November 2024)
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