Biosimilars and Biobetters

The industry needs a clear regulatory pathway for the approval of biosimilars.

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.

In late June and early July, the US Congress moved forward on three important bills affecting the biopharmaceutical industry, related to follow-on biologics, the Prescription Drug User Fee Act (PDUFA), and the 2008 FDA budget.

The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.

The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.

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.