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If purely immunogencity is the hurdle, then approval is not far away. Teva should already have the data submitted.
kindly disagree. Much tougher to answer immunogenicity question.
Immunogenicity here means proving drug safety without going through extensive clinical trials. You think FDA would make this easy?
Read paragraph 2 for an idea on immunogenicity hurdle.http://pharmalicensing.com/public/articles/view/1106647009_41f617e1d6d25