The MAA is based on results from two global Phase III clinical trials that examined the efficacy, safety and pharmacokinetics of Alprolix for hemophilia B.
The two trials include the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12.
Currently, Alprolix is approved for the treatment of hemophilia B in the US, Canada, Japan and Australia.
The company said that Alprolix is the only approved hemophilia B therapy to demonstrate prolonged clotting factor circulation in the body.
Biogen Research and Development executive vice-president Douglas Williams said: "The acceptance of this MAA is an important milestone in our goal to bring this innovative therapy to the European hemophilia community.
"We look forward to working with European regulators to help people with hemophilia B in Europe realize the benefits that treatment with Alprolix may offer."
Both the companies have collaborated in the development and commercialization of Alprolix for hemophilia B.
Sobi has an opt-in right to assume final development and commercialization of Alprolix for the Sobi territories essentially, Europe, North Africa, Russia and certain Middle Eastern markets.
As part of the collaboration, Biogen leads development for Alprolix and has manufacturing and commercialization rights in North America and all other regions in the world excluding the Sobi territories.