Biotech Values

[DewDiligence]

Re: Miller and biogenerics

Let’s look at Miller’s statement one more time because it’s such a gem:

“Biosimilar Producers: With the 12-year exclusivity written into the proposed PDUFA legislation, don’t bother. If you do bother, realize you are investing in a pack driven by perception and not fundamentals. Be nimble and don’t get greedy”.

I concur with the points BI raises in msg #50607. However, I think Miller’s main misunderstanding of the biogenerics arena is that he thinks 12 years of exclusivity will be applied to already-approved biopharmaceuticals with a brand new clock.

Let’s take Novo-Nordisk’s blockbuster NovoSeven as an example. The U.S. patent on NovoSeven will expire in 2011, allowing biosimilar FVIIa products to enter the market at that time. But Miller evidently thinks that NovoSeven will get 12 years of brand new marketing exclusivity when a biogenerics bill is signed into law. It doesn’t work that way!

(I expect that Miller will now say, No, he never meant to imply that there will be 12 years of new exclusivity for existing biopharmaceuticals. But there is no other sensible way to interpret Miller’s silly comment quoted above.)

The reality of the emerging biogeneric/biosimilar field is that there are approximately $65B (!) of annual sales from biopharmaceuticals that are either off-patent already or will be off-patent within the next few years. I’ve posted a table of such products in #msg-20699044.

If biogenerics is not a robust area for biotech investing, then nothing is.