Biotech Values

[hmpa]

Except for "politically sensitive" situations (Lovenox/m-Enoxaparin being the prime example, and we are not talking lack of budget here), FDA almost never delays first few ANDAs for a particular drug - whose launch results in a major price drop. For many popular drugs, as many as 10 or more ANDAs are eventually filed. One could argue that the system benefit of yet increased competition (between the generics) is marginal, while FDA's resources have to be spent not only on the initial approval (including inspections, etc.) but on the continued support of the marginal producers, too. In particular, extreme level of competition between the generics companies encourages them to go to the cheapest API suppliers (while with the approved DMF, but still the least FDA-inspected outfits in India and China). To me, once the initial generic launch(es) occur, there is no reason to be upset about the follow-up ANDA fate (unless you are heavily invested in the company that submitted them).