Biogenerics - a big opportunity but also a bigger backlog?

In my post yesterday, I described some of the steps that the FDA is taking to unclog the backlog for generic drug approvals. A new report published by Datamonitor - Is the biogenerics battle about to heat up? - talks about biogenerics as the next battleground.

"Espicom Business Intelligence reports that biological drugs account for 10% to 15% of the world pharmaceutical market, about $30 billion in the US alone. Datamonitor’s analysis concludes that global sales of biologics by top pharma and biotech companies reached $56.2 billion in 2004, up 18.3% from 2003. And the biologicals sector is outperforming the pharma industry as a whole, Espicom says. But the development of the biogeneric sector faces significant obstacles, the group predicts. While generic versions of off-patent chemical-based products have had great success, biogenerics, Espicom says, are expensive to develop and the nature of the current regulatory system precludes approval in most cases, particularly in the US, where the FDA has yet to issue detailed guidance on biogenerics."

There is already great opposition from the branded pharma community, which claims a biogeneric product (a protein) cannot be considered an bio-equivalent without a full clinical trial. In addition, branded pharma companies are likely to deploy many other defensive maneuvers, such as litigation and lifecycle management strategies.

This will be an important area to watch over the next few years.