For Biosimilar Developers, Honeymoon May Be Over

Law360, New York (March 15, 2013, 7:16 PM EDT) -- Three years after the Affordable Care Act created a way for the U.S. Food and Drug Administration to approve biosimilars, regulatory and market uncertainty has curbed many drugmakers' hopes of cashing in on a new superlucrative market, with some now questioning whether developing a biosimilar will ever make good business sense.

Under the ACA, the FDA was instructed to create a pathway for approving biosimilars, also known as follow-on biologics, which are akin to generics for traditional, small-molecule drugs. Much of the impetus was to create...
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