Biogeneric approvals on the way?

The market for generic biologic drugs is forecast to reach nearly $12 billion worldwide in 2010. Though such numbers indicate that the generics industry is on the rise, with several blockbuster drug patents set to expire in the next five years, regulatory obstacles could hinder biogeneric development, says a new report from Cutting Edge Information.

The US Food and Drug Administration's current drug approval process does not support biogeneric reviews, but this may soon change. Under debate is how companies prove that complex biogenerics are equivalent to, and as safe as, branded counterparts. "Though an approval process is needed, the amount of testing required to prove bioequivalence between generic and branded biologics is unclear," said Cutting Edge Information senior analyst Jon Hess. "Traditional generics can be compared to branded drugs through chemical specifications, but biologics contain large molecules and there is a capacity for unpredictable interactions with human bodies. This generates some safety uncertainty," he added.

Both biogeneric manufacturers and biotechnology companies are actively lobbying the FDA and US Congress to influence guidelines for biogeneric approval. Once an adequate approval process is in place, biogenerics will become an alternative for consumers demanding price relief. However, notes Mr Hess, "the price of producing biogenerics creates different cost structures for generics firms. The biogeneric marketplace could look very different from the conventional generics marketplace we know now."