Sauce for the goose and gander in biotech
May 9th, 2007 by 
David E. Williams of the Health business blog
“What’s sauce for the goose is sauce for the gander,” the old expression goes. In other words, what’s good enough for one person should be good enough for another.
How does this apply in biotech and the ongoing debate on biogenerics?
The biotech industry has lately made the following contentions:
- We don’t mind generic competition, but generic companies should have to conduct full-blown clinical trials before introducing their products to the market because how else can we be sure their products are therapeutically equivalent?
- Follow-on products should be considered as “bio-similars,” not directly substitutable for the original product, because the follow-on product will never be exactly the same as the original product
If the biotech industry were to apply those same principles to itself, they’d have some serious problems:
- When a biotech company changes its manufacturing process, it just runs a bioequivalence study with a limited number of patients and limited cost. Why should a generic company need to do more than that for its new process? Or are biotech companies prepared to redo all their clinical work when they make a major change in the production process?
- As a representative of an analytical testing company told me yesterday, his company’s methods often detect significant differences from one batch to the next of the same biotech product. So is the industry saying that its own products should also be considered “bio-similars” or that physicians should write a prescription for a specific batch rather than a specific product?
Like I said yesterday (Credibility and prosperity in biotech)
You shouldn’t exaggerate the truth to get your point across. It could come back to bite you.
The truth should be good enough.
Posted in Economics, Pharma, Policy and politics, Technology | 
3 Comments »
May 14th, 2007 at 12:37 pm
[...] David Williams in the Health Business Blog has another commentary on the need for unvarnished truthfulness in biotechnology. The examples he uses are germane to the debate about generic biotech drugs. In particular, biotech firms contend that different manufacturing processes produce different molecules, so that generic biotech drugs should undergo full-scale clinical trials. So then why do biotech firms only do limited bioequivalence studies when they switch their manufacturing processes? And since these firms often find batch-to-batch variation in their own products, should each batch undergo separate clinical trials? [...]
June 6th, 2007 at 8:15 pm
[...] That sounds very reasonable, until you realize that requiring full-blown clinical trials, and then also insisting that such generics not be considered fully substitutable, would be enough to prevent a biogeneric industry from emerging. As I’ve written, the industry doesn’t like to admit that its own products aren’t necessarily identical from batch to batch. Plus, when they make process changes they just do bioequivalence studies, not full phase III trials. That should be good enough for generic companies, too. (Though I actually think Genentech should be allowed to keep its post-patent monopoly, albeit at a regulated price.) [...]
February 17th, 2008 at 9:06 am
Hi David.
Like the rest of the world, I am also looking at the biogenerics scenario that is playing itself out in the US.
I think your post rather bluntly puts the right message across. “Physicians should write a prescription for a specific batch rather than a specific product?”
Unfortunately, investors including Angel and Devil ones have had their work cut out in biotech companies. They thought complexity would deter others from delving into the Myozymes.
If what the Congress wants could really be put into action, then biotech firms would lose their so called ‘perpetual’ advantage.
That’s what is bugging them so much and mind you, they would go to all lengths to protect them! A friendly administration could cut them some slack. Is the current government inclined to do it?