When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.
A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.
European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.
Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.
While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.
Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.