Biosimilars and Biobetters

In the US, the patent term is 20 years from the filing date . . . commercial product may lose patent protection just as sales are ramping up.

Congress is not considering legislation that would expand FDA authority to regulate biologics.

Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.

Of all the protein products on the US market, at most 75 are likely to become genericized.