QDIS Blog

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.

GPhA Hails Omnitrope Approval

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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Mark Senak over at Eye on FDA posted about the possibility of a recess appointment for current acting FDA commissioner Andrew C. von Eschenbach. He makes some very good points and I tend to agree with him concerning the possible damage to the FDA if Dr. von Eschenbach should be appointed during a congressional recess.

By opinion though is the current administration really doesn’t care about that. The same argument applies to John Bolton and his appointment to the UN. I think there is a real possibility this will indeed happen especially since, as Mark point out, Dr. von Eschenbach has already resigned from his post at the NIH. I’m sure the administration has given him some sort of “guarantee” before he resigned form the NIH. I also think that if a recess appointment does occur, Dr. von Eschenbach will almost certainly be another short-time leader of the FDA. I really think this is too bad but that’s how I read the tea leaves at the current time.

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