Biosimilars Dodge Bullet As High Court Upholds ACA

Law360, New York (June 28, 2012, 12:52 PM EDT) -- Manufacturers of biologic drugs breathed a sigh of relief Thursday after the U.S. Supreme Court narrowly upheld the Obama administration's health reform law, which includes revolutionary changes to the industry’s approval process, experts said.

One of the law’s most relevant provisions for pharmaceutical firms created an approval pathway for biosimilars, the generic equivalents of high-priced brand-name biologics. Many manufacturers had anxiously awaited the high court’s ruling, fearing it could erase that authorization and set the industry back months or years.

“This is a huge victory for...
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