If they file as sNDA, it means it is deemed as same drug as Copaxone, asking to expand the drug label. If FDA require them to file as NDA, it means it is considered as a different drug from Copaxone. sNDA is supplement to original NDA, referencing directly to all previously submitted contents, while NDA allows to reference some other sources outside of the submission via 505b2, but NDA mostly stands on its own.
One example from the past was Myozyme/Lumizyme. Originally 2000L version was submitted as sBLA to Myozyme, but FDA deemed 2000L was a different drug from Myozyme, thus it was later filed as stand alone BLA based on a different pivotal trial, approved as Lumizyme. If Copaxone 3x weekly filed as new NDA, it will have a new name if approved.
As of benefit, I don't think it matters that much, with mere convenience without added efficacy or safety, I don't think insurance would pay the premium once Copaxone becomes generic whether it is the same drug or different drug. Obviously Teva thought differently.
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