In anticipation of Congress enacting a law that creates a regulatory pathway for creating generic versions of expensive specialty drugs, Merck, the pharmaceutical giant, announced that it is creating a division to manufacture biogenerics also known as "follow-on" biotech drugs. According to a Forbes.com article, Pfizer is making a similar move.
Forbes.com explains that "biotech drugs are hard-to-make proteins that will require their own clinical trials. It might cost $300 million to develop a biotech copycat. As a result, these drugs will cost only 30% or so less than branded versions, meaning a single biogeneric could generate hundreds of millions in sales." Nevertheless, I have heard industry leaders such as Medco's CEO David Snow express excitement over the savings that biogenerics will create for consumers and health plans. I hope that 2009 will be the year that Congress finally gets off its tail and passes the necessary law.