At Wednesday’s 2010 Biotechnology Vision Summit in Madison, WI, Biotechnology Industry Organization (BIO) president and CEO James Greenwood was still bragging about his victory to keep a 12 year FDA data exclusivity clause for biosimilars.
And so he should be.
BIO was up against Senator Hilary Clinton and Congressman Henry Waxman, who introduced an earlier bill that provided zero years of data exclusivity for biological drugs. This was in agreement with a report by the FTC suggesting that no exclusivity period is required because current patent protections would offer sufficient incentives for biological drug development.
Influential social welfare group AARP also weighed in, saying that they would support an exclusivity period of only seven years.
Greenwood firmly believes that patent laws don’t protect large molecule drugs in the same way that they do for small molecule drugs. The “patent protection gap” exists, according to Greenwood, because a biosimilar drug can gain approval based on the fact that it has the same clinical effects as a previously approved drug, even if it is different in structure.
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| James Greenwood at the 2010 Biotechnology Vision Summit. |
A long exclusivity period would hamper efforts by follow-up companies to develop competing treatments and, in turn, give innovators confidence that they will be able to recover research and development costs.
Believe it or not, Greenwood is not against the production of generics or biosimilars. In fact, he believes that they generate healthy competition for the industry. But he is unwavering in his belief that legislation must encourage innovation ahead of anything else.
Rod's Revelation
Every keynote speech has an anecdote, but with ex-Illinois Governor Rod Blagojevich’s trial making headlines over the past week, this was possibly the most timely. The story began at a conference — years ago, I assume — where Blagojevich read an in-depth speech on “everything you would need to know about biotechnology,” recalled Greenwood.
Afterwards, the two men walked to a different part of the conference. As if he had never given the speech, Blagojevich turned to Greenwood and said “what the heck is this biotechnology stuff about anyway?”
After a few unsuccessful attempts, Greenwood broke it down like this:
“See all these people? They are trying to heal the world, feed the world and fuel the world.”
It’s an ambitious task and a great story behind what became BIO’s slogan.