On The Cusp Of Biosimilars: Reform Ushers In Next Generic Drug Era
The health care reform legislation signed into law by President Obama March 23 paves the way for the launch of biosimilar drugs in the U.S., action that could save the country's health care system billions of dollars, while presenting both challenges and opportunities for the drug industry
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The big pharma has five biosimilars in Phase III development with its partner Samsung Bioepis, and expects to file them for regulatory approval in 2015 and 2016.
The generic specialty injectables firm expects to file a biosimilar version of Amgen’s Epogen in the U.S. in late 2014, potentially positioning it for its first U.S. biosimilar launch in late 2015.
The Generic Pharmaceutical Association's reunification is not entirely complete. Hospira, alone among large firms that had left the association, has opted to remain a former member.