Last reviewed 2026-04-22 · How we verify

Eptacog alfa, biosimilar

Eptacog alfa is a recombinant activated Factor VII that bypasses upstream coagulation defects to directly activate Factor X and initiate thrombin generation for hemostasis.

Eptacog alfa is a recombinant activated Factor VII that bypasses upstream coagulation defects to directly activate Factor X and initiate thrombin generation for hemostasis. Used for Hemophilia A or B with inhibitors, Factor VII deficiency, Glanzmann thrombasthenia with refractoriness to platelet transfusion.

At a glance

Mechanism of action

Eptacog alfa (recombinant Factor VIIa) is a vitamin K-dependent serine protease that activates the extrinsic coagulation pathway independently of Factor VIII or Factor IX. It binds to tissue factor on cell surfaces and directly activates Factor X, leading to thrombin generation and platelet activation. This mechanism allows hemostasis in patients with Factor VIII or Factor IX deficiency, inhibitors to these factors, or other coagulation disorders.

Approved indications

• Hemophilia A or B with inhibitors
• Factor VII deficiency
• Glanzmann thrombasthenia with refractoriness to platelet transfusion

Common side effects

• Thrombotic events (deep vein thrombosis, pulmonary embolism, myocardial infarction)
• Injection site reactions
• Fever
• Headache

Key clinical trials

• Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency (PHASE3)
• Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors (PHASE3)

Primary sources

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