 While the FDA will not approve biosimilar applications for Eculizumab before 16 March 2019, there is an ongoing debate over the length of exclusivity periods.National regulators protect orphan drug producers from competition with biosimilar products through a multi-year exclusivity period, it is challenged as markets open and international trade deals are negotiated —such as the Trans-Pacific Partnership (TPP).A generic version, branded "Elizaria'", is available in Russia.