Via Twitter, Kyle Serikawa makes an interesting suggestion regarding biomolecules and small molecules (emphasis mine):
...I think we should trade the 12-year exclusivity period from biologics to small molecule drugs.
Why would this help? Because small molecule drugs are far easier to copy and far easier to produce than biologics. Extending the exclusivity period for small molecules at the expense of biologics might provide the incentive needed to get biopharma to ramp up their chemistry departments again. And in the long term, more small molecule drugs could not only address a lot of serious illnesses, but would also mean more drugs will eventually be made available at extremely cheap prices once they become generic, rather than the more modest 20-50% discount expected for biosimilars (the generic version of biologic) drugs....
...There are practical reasons to try to do this now. In the world of biopharma, small molecule approaches have been losing favor to biologics because biologics can command higher prices, are harder to copy, face less severe competition, and tend to have much longer product life cycles. Given the attractiveness of biologics from a business standpoint, the industry has curtailed its discovery efforts around small molecules. A generation of expertise in medicinal chemistry is growing older and the few scientist replacements aren’t being trained quickly enough in all that institutional knowledge. Persuading biopharma to go back to small molecules would help stem the loss of knowledge, which would increase the odds of creating great, eventually generic small molecule drugs.Is it really true that "the few scientist replacements aren't being trained quickly enough"? Is there a demographic gap between soon-to-retire medicinal chemists and their younger replacements? I could believe such a thing, but I'd like to see some data.
Dr. Serikawa suggests that this would be a good long-term idea for the country; I'm inclined to agree (seeing as how the point is "employ more medicinal chemists".) Somehow I doubt biopharma management and their shareholders would agree, though.
Would a President Trump agree to this? It scratches his "drugs are too expensive" itch, and that might be worth something. I can't imagine that pharma-oriented senators would be excited, though.
I would trade longer exclusivity for a better system to negotiate down drug pricing. Maintain or increase AUC of return over time but push it out over a longer time period. I'd assume that would make companies think on a longer time scale (sorry doesn't really address how to get more chemists working) and would minimize some of the legal costs associated with patent disputes. Compounded on exclusivity, an odd thought of mine would be to allow companies long time patent lifes on composition of matter patents (30 years) as long as there are mechanisms to combat pricing (annual caps, yearly renogotiations, etc.). I don't understand why generics have to be the mechanism by which we combat pricing? Why have redundancy of making the exact same chemical matter that is already being produced by the inventors? Seems like a waste, I'd also assume the number of patent disputes would be reduced. More costs savings there. Just kind of tired of seeing pharma companies putting so much money into sales and legal malarky rather than more into R&D.
ReplyDeleteOne should bear in mind that a major reason why biologics/NBE are so attractive is their unmatched specificity which is a major advantage over most small molecules where the dose really defines the poison. That isn't to say that biologics don't come with side effects but they're usually not off-target effects but driven by the pharmacology of their very target. Combine that with the potential to achieve once monthly or even bi-monthly dosing or - if needed - tuneable half-life by using nanobodies and similar technologies and you can see the unique appeal of these technologies. And if you head an industry research department, you really want to select the approach that's most likely to result in a phase 2 (and obviously eventually marketed) drug.
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