Let’s come back to Zolgensma, the $2.1 million gene therapy for SMA that saves the lives of infants like Kaylee Price. What will happen when Novartis’s patent on Zolgensma expires?
This isn’t a question just about Zolgensma. By some estimates, there are more than 100 gene or cell therapies approved and marketed worldwide and thousands more in development. These drugs are much more complex to manufacture than small molecules like Lipitor, and even biologics like Humira or newer modalities like antibody-drug conjugates or bispecific antibodies. No doubt many of our most complex medicines will not face traditional generic competition.
And while we expect generic drugs to be just as safe as branded drugs, the stakes are higher with a one-dose genetic treatment than with a once-a-day blood pressure pill. At present, there is essentially no mechanism to genericize these modern medicines.
That’s a breach of the biotech social contract waiting to happen. We should look to policy fixes to solve this problem. We’ll discuss this further in Chapter 6.