Emicizumab Drug Substance Suppliers & Bulk Manufacturers

Available Forms: Drug substance (bulk)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Hemlibra

Category: Active Pharmaceutical Ingredient

Emicizumab is a humanised bispecific IgG4 antibody that bridges factors IXa and X for haemophilia A prophylaxis. It is sourced by biosimilar developers and biologics CDMOs.

Product Description:

Emicizumab is a bispecific monoclonal antibody that binds activated factor IX with one arm and factor X with the other, taking over the bridging role of the missing factor VIII in the clotting cascade. It has no structural relationship to factor VIII, so factor VIII inhibitors do not affect it. In the US it is approved for routine prophylaxis to prevent or reduce bleeding episodes in people of all ages with haemophilia A, with or without factor VIII inhibitors (reference brand: Hemlibra).

Specification at a glance

Regulatory files and timing

Biologic drug substance is usually supplied in bulk under a long-term supply agreement, or licensed together with the dossier, rather than bought as a one-off API order. Buyers typically ask for the drug substance comparability package, cell bank and process documentation, and the supplier's GMP status.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (Nov 2029). European Union: Patent expiry; entry not confirmed (Feb 2028-2029).

Handling and quality points

Because emicizumab has two different binding arms, the process has to remove mispaired and homodimeric species that a standard antibody process does not produce, and the analytical package must measure them reliably. Drug substance is kept and shipped under a validated cold chain in line with the developer's stability data; the finished product is refrigerated and must not be frozen or shaken. Buyers should also review viral safety, host-cell protein and DNA clearance, and glycosylation and charge-variant profiles.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.