“Whatâ€™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 shouldnâ€™t exaggerate the truth to get your point across. It could come back to bite you.
The truth should be good enough.May 9, 2007