Sandoz gets precedent-setting US approval for Omnitrope®
Wow, I must say I was very much surprised to learn this morning that the FDA has approved Sandoz’s generic version of the human growth hormone Omnitrope ® (somatropin). Here is a link to the page that contains the press release.
Sandoz gets precedent-setting US approval for Omnitrope®
Here is The Generic Pharmaceutical Association (GPhA) view of things from Yahoo finance.
They claim that this proves there is indeed a “pathway to approval” for biogenerics.
I’ve written about generic biologics previously. I really think this may be a mistake. Approving a biogeneric without some kind of process in place is just asking for trouble in the future. While I realize that Sandoz has spent some time and effort in the development and has been waiting for quite some time, it still doesn’t make sense to approve a biogeneric without a process in place. My experience with most companies and projects that are new and don’t have at least a basic mutual understanding of what is required are usually either doomed to failure, or end up in a lawsuit. This one is already starting with a lawsuit since Sandoz had to sue the FDA to get them to act.
The FDA has posted a Q&A page on Omnitrope and here they lay out their rational behind the decision and classify it as a “follow-on protein product”. They specifically state that it is not a generic biologic. Here the pertinent part:
Is Omnitrope a generic biologic?
No. Omnitrope is not rated as therapeutically equivalent to (and therefore substitutable for) any of the other approved human growth hormone products. Omnitrope is more appropriately characterized as a “follow-on protein product.”
I’m not sure how this is going to shake out with other companies that are contemplating introducing biogenerics (or should I say “follow-on protein products”). I can only hope that the FDA will put together guidance documents out for those who are considering “follow-on protein products” (FOPP?). I still think biogenerics sounds better. FOPP just has sounds negative to me; too much like flop. And no one is going to spell out “follow-on protein product” every time.
Other sources for news on this:
• USATODAY.com - FDA approves growth hormone
• from the SF Chronicle: FDA Approves Growth Hormone
• Novartis wins landmark US biogeneric approval - Yahoo! News
Technorati Tags: biogenerics, FDA, somatropin
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