April 2, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Looking for all the major biosimilars in development? Look no further—well known biotech analyst and medical doctor Mark Schoenebaum of ISI Evercore has compiled a comprehensive list, as BioSpace continues to follow this game-changing story.
Swiss drugmaker Novartis AG won approval from the U.S. Food and Drug Administration (FDA) for the nation’s first biosimilar drug March 6, after the FDA said the company could now sell its white blood cell drug Zarxio, a knockoff of Amgen ’s blockbuster treatment Neupogen, or filgrastim.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret Hamburg. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010. Now, as the industry braces for change unprecedented since the advent of generic drugs, market watchers are scrambling to see what companies could possibly see their own pipelines threatened by knockoffs—and how regulators might approach this thorny issue.
GRAPHIC COURTESY OF ISI EVERCORE:
