Print“Our policies and regulations must continue to encourage American healthcare innovation in the field of Biologics, but it is also our responsibility to ensure all Americans have access to affordable therapies.”
A high-stakes fight over just how early competitors can begin crafting copies of innovative biologic medicines is underway on Capitol Hill. The winning side stands to reap millions of dollars as the U.S. Food and Drug Administration decides whether the word “exclusivity” in health care reform legislation applies to both data and market access, or just market access alone.
Biotechnology companies and their backers insist legislators writing the Biologics Price Competition and Innovation Act intended a 12 year lock on both market access and the proprietary data behind their novel therapeutic medicines. Without strong data exclusivity protections, the biomedical industry loses its incentive to innovate, argues the Biotechnology Industry Organization.
Insurers and the developers of biosimilars, drugs that mimic original biologics without being exact copies, say that Congress meant to protect the data for as little as four years rather than the full 12 years of market exclusivity. That interpretation would allow them to get an early start on developing their copies, allowing them to be ready to compete with original therapies as soon as 12 years is up.
Now a bipartisan group of United States senators has waded into the scuffle urging the FDA to reject efforts to “further block or delay affordable generic competition.” The Senators—Arizona Republican John McCain, Ohio Democrat Sherrod Brown, New York Democrat Charles Schumer, and Iowa Democrat Tom Harkin—asked the FDA to disregard efforts to “needlessly delay consumers’ access to generic biologics.”
“Our policies and regulations must continue to encourage American healthcare innovation in the field of Biologics, but it is also our responsibility to ensure all Americans have access to affordable therapies through a fair, competitive generic biologics pathway,” say McCain.
The 12-years of market exclusivity in the 2010 healthcare reform represented a hard-fought victory for the biotech industry. There’s no question a big wave of competition will eventually come to high-priced biologics. The complex and hard-to-develop drugs are expected to make up half of the sales from the Top 100 medicines by 2014, making them a fat target for imitators hoping to cash in on their value and insurers looking to cut their expenses. But with billions of dollars of revenue on the line, drugs developers trying to protect the high premiums that innovative medicines fetch are going to do what they can to ensure that competitors catch up later rather than sooner.
January 27, 2011
http://www.burrillreport.com/article-brawl_over_exclusivity_heats_up.html
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