You are absolutely right. Not only has the process not been approved, there is not a single recombinant enzyme approved by the FDA which is made in plant cells. They would be breaking major new ground if they were to get approved, therefore the likelihood of this happening on first cycle with the paucity of clinical data they have is quite low. FDA is only going to begin taking up biosimilar issues later this year, making it all the less likely they will approve before the discussions and regulatory decisions have been made.
This is the headfake from the company I've been expecting, and those who get suckered in by this Israeli company are going to be sorely regretful in the next few days.