Gillian Woollett, MA, DPhil, senior vice president, Avalere Health, explains potential consequences if the United States were to do away with biosimilars.
Gillian Woollett, MA, DPhil, senior vice president, Avalere Health, explains potential consequences if the US were to do away with biosimilars.
If the US were to do away with biosimilars in favor of price regulation for innovative drugs, what might happen to biosimilars in the rest of the global market?
Well, I think we have to start with how totally un-American it would be and I say this as a putative ex-Brit and definitely American. It would be to just do away with a potentially competitive framework. Now, there's no question biosimilars are struggling in the US. Insofar as they're struggling, maybe there's some changes that are needed to the pathway to enable them to actually get to market, get through what's been known as the patent thicket, and then have commercial models. But to unilaterally just dispose of a pathway that's allowed 23 products to be approved, strikes me as awfully premature and probably not helpful for anyone. Now, in terms of the rest of world, I do think there's a bigger sub-question to what you asked. That is, if the US doesn't succeed and doesn't provide the return on investment (ROI) for the substantial dossiers that are being compiled, about $100 million to $500 million it's costing—which is 100 times that of the average generic—if the US is not providing the ROI for a biosimilar, what does that mean for the global market? I think there's a very real risk that the rest of the world cannot provide the ROI that we in the US do, given we're 60% by dollar value of the originator biologics market.