Humira is the kind of megablockbuster medication that all Big Pharma companies dream about. It reliably earns more than $3 billion a year in the U.S. and is projected to grow into the number one slot among top global earners this year. And as Abbott ($ABT) readies a spinoff of its pharma unit into AbbVie, the threat of biosimilar competition threatens to bring the franchise down.
But Abbott isn't sitting on the sidelines as competitors start to circle. Instead it's filed a citizen's petition that claims that the FDA would have to get hold of its trade secrets for Humira before it could determine if it had been properly copied. And, the company argues, no biologic approved before the biosimilars legislation was passed, along with the Affordable Care Act in 2010, should face copycats, as The Wall Street Journal explains in an in-depth article today.
Critics, though, are scoffing at Abbott's sudden concern about trade secrets and the law, noting the pharma company appears to be motivated primarily by the desire to retain the franchise.
"This is about money and their company," Rep. Anna Eshoo, a Democrat who spearheaded passage of the legislation, tells the Journal. "They want to back off it for their own self-interest."
Genericsmaker Hospira ($HSP) says it's seen it all before in the fight over small molecules. "We think the case for biosimilars is compelling."
Curiously, Abbott's best shot at thwarting competition in the U.S. is in the hands of the U.S. Supreme Court, which is considering throwing out the entire ACA, and the regulatory pathway for biosimilars which is included.
- here's the article from The Wall Street Journal