Forecasters say the market for generic biologic drugs will reach nearly $12 billion worldwide in 2010.  Though such numbers indicate that the generics industry is on the rise – several blockbuster drug patents will expire in the next five years –  regulatory obstacles could hinder biogeneric development. 

The FDA’s current drug-approval process does not support biogeneric reviews.  This situation may soon change: a recent article in the Wall Street Journal reported that the FDA is laying early groundwork for generic versions of biologic medicines. 

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 Eric Bolesh.  “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.”

Both biogeneric manufacturers and biotech companies actively lobby the FDA and US Congress to influence guidelines for biogeneric approval. Once an adequate approval process is in place, generic biotech drugs will become an alternative for consumers demanding price relief.  How much price relief, however, is unclear.  “The price of producing biogenerics creates different cost structures for generics firms,” said Hess.  “The biogeneric marketplace could look very different from the conventional generics marketplace we know now.”

In its report on the topic, “Combating Generics: Pharmaceutical Brand Defense,” Cutting Edge Information showcases competitive strategies from both branded and generic biologic makers. The report contains strategies from Sandoz, Genentech, Eli Lilly, Mylan Laboratories, and Teva Pharmaceuticals.

To download a summary of this 164-page report, visit http://www.PharmaGenerics.com. For more information or to learn about other Cutting Edge Information research, contact Diana Borja at diana_borja@cuttingedgeinfo.com or 919-433-0219.

 
<-- Back to the News Page

<-- Back to the Cutting Edge Information home page