Sandoz Secured Rights for Hemlibra Biosimilar

The agreement adds to a 40-asset pipeline, expanding potential access to treatment for hemophilia A.

Updated on Oct. 13, 2026 in Biotech

Sandoz Secured Rights for Hemlibra Biosimilar

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Sandoz announced on September 18, 2026, that it reached a development and commercialization agreement with mAbxience for a proposed biosimilar to Genentech HEMLIBRA. This deal focuses on a treatment for hemophilia A and marks a new addition to the Sandoz biosimilar portfolio.

Why it matters

The collaboration leverages the manufacturing capabilities of mAbxience to bolster the Sandoz biosimilar strategy, which now reaches 40 total assets. This move positions Sandoz to expand its market presence in global therapeutic areas currently dominated by branded biologics.

The biosimilar portfolio at Sandoz has expanded to 40 assets following this agreement. While the pipeline size is confirmed, the specific manufacturing specifications for the Hemlibra equivalent remain subject to development milestones.

The players

Sandoz

A global pharmaceutical company focused on generic and biosimilar medicines with a growing pipeline of 40 assets.

mAbxience

A biopharmaceutical firm specializing in the development and manufacturing of biosimilar products.

Genentech

A biotechnology company and subsidiary of Roche that manufactures the hemophilia A treatment HEMLIBRA.

The details

The partnership assigns product development and manufacturing responsibilities to mAbxience, a firm specialized in biosimilar development. Sandoz retains exclusive commercialization rights for the global market, with the specific exclusion of operations in Argentina, Uruguay, and Paraguay.

Timeline

  1. September 18, 2026: Sandoz and mAbxience announced the biosimilar development agreement.

The Tech Race

The development of a biosimilar to HEMLIBRA places Sandoz and mAbxience directly into the competitive field of coagulation factor replacement and mimicry. This effort reflects a broader industry trend toward creating cost-effective alternatives for complex biologics.

Patients and healthcare providers should view this as a long-term development pipeline update rather than a near-term availability shift. The agreement secures the development path, but commercial access will depend on subsequent clinical and regulatory milestones.

The takeaway

This agreement signals a major expansion of the Sandoz biosimilar pipeline to 40 assets targeting established biologics. Stakeholders should track future regulatory filings and clinical progress updates from the two companies to gauge the timeline for market entry.

Further reading

Explore deeper shifts in the Biotech landscape as firms scale their biosimilar pipelines.

Source note: This article includes information reported by Big Molecule Watch.

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Do you believe collaborations between pharmaceutical companies to create biosimilars ultimately benefit patients?