I attended the hearing in the Energy and Commerce Committee on “Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States” that was held this Wednesday. Very interesting. I was pleased to see legislation for an abbreviated pathway to allow the creation of generic versions of biotech drugs, similar to what the Hatch-Waxman Act did for chemically-based drugs 23 years ago, seems to have broad bipartisan support.
I think the FDA is ready to go to get these types of drugs in the marketplace as soon as possible – now they just need a law passed to do it. If legislation should get on the President’s desk this year and he signs it into law, it will still be a couple of years before we see generic biologics in the marketplace. So the sooner this gets done the better because it means taxpayers and consumers will be able to save a lot of money. I dropped off our new report, “Biogenerics: What They Are, Why They Are Important, and Their Economic Value to Taxpayers and Consumers” while at the hearing. Our study shows biogenerics could save taxpayers $43.2 billion during 2011-2020. You can find our study here.