Let’s a look at 3 real life drugs and follow the path they each followed from molecule all the way through to genericization. The 3 drugs are:
Lipitor, a small molecule drug in a class called statins, which lowers LDL (bad) cholesterol and reduces incidence of heart attacks. The Lipitor story is a great example of the biotech social contract and its impact on the generic drug market.
Gleevec, a blockbuster drug treating chronic myelogenous leukemia (CML) that had a more complex journey to becoming an inexpensive generic.
Humira, a biologic drug used for autoimmune conditions, which became the best-selling drug after Lipitor, generating over $200 billion. Initially, there was no pathway for generic biologics. This is beginning to change.
As you’ll see in the coming pages, each drug had its own unique journey, illustrating the difficulty of a creating a one-size-fits-all pathway to genericization.