I suppose this is as good a time as any for me to go on a rant:
A few weeks ago, I got to sit in on a few meetings on the emerging topic of "Bio-Similars". A biosimilar is a generic version of a drug, but not a small molecule drug like all of the generics you see - a generic version of a biotech product. A protein, antibody, or what have you. Some of these patents are about to expire, and some of these drugs are worth billions of dollars in sales.
The FDA finally opened up a way to apply for them, buried somewhere in the health care act. So how do you get one?
0) Make your own version of the original, then submit to the FDA AND the original company all of your documentation on the manufacturing process/etc.
1) Buy millions of dollars worth of the original drug
2) Do clinical trials to prove they're the same
Problems:
0) You're going to get sued for patents on EVERY step of the process, and you're disclosing everything to your competitor.
1) The original manufacturer will not let you buy millions of dollars worth of the original drug. They will claim that the supply is exhausted, or any of a million other things. You have to set up shell companies to buy thousands of dollars worth of the drug and then pool it all together later.
2) It's actually quite a bit more difficult to prove that two things are the same than to prove that one thing works, statistically.
Until something changes, there will not be a license granted for a generic version of any biotech-created drug. It's easier to get a completely new patent on the exact same thing (after you find some way to make an exact copy in a way that is "new" and "non-obvious" enough to get patented...). Except that's something that the original company will have already done as soon as their first patent expired.