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CHICAGO — 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.
The drug maker said it delivered more than 5 million doses of biosimilar medicines to patients in Europe and Australia. The convention includes multiple sessions devoted to such topics as biosimilar regulatory approval, manufacturing and market formation, the company said.
"Bringing biosimilars to the United States is the next major step toward reducing costs for the U.S. healthcare system," Hospira president Thomas Moore said. "As the first U.S. company to market biosimilars globally, Hospira will build on our track record of success to introduce biosimilars in the United States and increase access for Americans to high-quality, biologic medications that treat severe and life-threatening diseases."
The company said its products entered the European and Australian markets after "robust" regulatory approval processes and that they had been subject to extensive post-marketing studies to test their effectiveness and safety. By contrast, the Patient Protection and Affordable Care Act of 2010 contained provisions for an abbreviated biosimilar approval pathway in the United States, similar to the one for generic pharmaceutical drugs, but the Food and Drug Administration has yet to finalize and implement regulations.
Nevertheless, biotechnology companies in particular point out the fundamental difference between biosimilars and generic pharmaceuticals. Generic pharmaceuticals are made under the same process as their brand-name counterparts, but biotech drugs are made by manipulating the DNA of cells so that they churn out medicinal compounds. The sticking point is that because the cell line used by the maker of a brand-name biotech drug and that used by a biosimilar manufacturer would be different, there is the possibility that the original product and the biosimilar could differ in terms of safety and efficacy. As such, the regulatory pathway for biosimilars will require some clinical trials before the FDA can approve them, a process not required for generic pharmaceuticals.
At the same time, many states have sought to pass laws that would allow physicians to bar pharmacists from supplying biosimilars. Gov. Bob McDonnell of Virginia recently signed such a bill into law, and Florida's state legislature has advanced a similar law, but the laws contain sunset provisions, meaning they would likely expire before any biosimilars came to market.