At the beginning of the TEVA conference call, Shlomo claimed that FDA has agreed that their version is equivalent. The FDA is just looking at immunogenecity now.
Regardless of who said what when,
The claim is "chemical sameness" has been established.
Read the FDA 5 criterion. This is half of the first item.
So even if true it means little.
The immune screen is also one item, and vastly more sensitive than the chemical formula sameness.
And they have 3 1/2 other items to meet.
And why is it now over 7 years for them? They claimed in August they were a month or behind Sandoz due to later submission of the immune response data. Well, that delay is well past.
There's a chance that the FDA tried to be tight lipped and said, "we have completed our chemical equivalence review and it is now being reviewed by the biologics group for the immunogenecity portion." Meaning that they will be doing a complete review regardless of outcome. Which may mean they reviewed the chemical equivalence piece, concluded there were issues, but wanted to give TEVA a complete response.
The ever-optimistic Shlomo heard "the chemical equivalence portion is approved, we're waiting for the immunogenecity piece."
I talked to someone at the FDA. They said the stuff in my garage is almost Lovenox too! I am not sure what they do at FDA; secretary or something. Real FDA people don't make casual comments!!!
Technically he didn't tell a lie since he didn't define "we" like Clinton's definition of non-sex sex with Monica. It was a nice impressionistic painting though. Shlomo would have done well as a broker of subprime CBOs derivatives at Goldman Sachs.
Agree. That is what confused me when I heard that FDA agree upon equivalence. I thought too Teva API has different characters, regardless where it is coming from. But I have no reason to think that Shlomo would lie through his teeth at the conference call. Do you have any ideas?
Good point. Like you said the structure was characterized by other methods. Momenta knows how to characterize and they have couple of patents granted. Also, they helped the FDA with the heparin contamination issue so they know how to determine impurities. I don't know TEVA's capabilities here. TEVA filed the ANDA before MNTA but MNTA got the approval first. That means TEVA lacks somewhere.
I would agree with you 100% if this is a protein based therapeutics. However, here structure or sequence was determined by other methods. MNTA has already gone through this with FDA and the decision was that the prevalence of heparin induced immunogenicity is so low (statistically) that it does not make sense to run a separate study.
It's not just about impurity, it also has to do with structural integrity of the product. Even a minor change in the structure could lead to a different immune response whether harmful or harmless.