Thursday, April 29, 2010

1st independent, dedicated biosimilars manufacturing facility in the US at IIT in Chicago

Therapeutic Proteins Inc. this week announced the completion of the nation’s first independent, dedicated biosimilars manufacturing facility constructed to meet U.S. FDA requirements. The Chicago facility is located at University Technology Park at Illinois Institute of Technology.  Therapeutic Proteins will relocate from Deerfield, IL, to a new 13,000-square-foot facility at IIT in May.

The company makes raw ingredients for cheaper "biosimilar" or "biogeneric" versions of drugs derived from biotechnology, such as the anti-anemia brand Epogen. For now, biogenerics are available only outside the U.S.

Biotech brands such as Epogen are unavailable in the U.S. in biogeneric form because they were not part of the 1984 landmark Hatch-Waxman law that allowed for cheaper generics. That law largely covers products derived from chemicals, such as the cholesterol drug Zocor and the antidepressant Zoloft.

Under the health care reform legislation passed by Congress and signed into law last month by President Barack Obama, lawmakers finally cleared a path for the U.S. Food and Drug Administration to approve biogeneric drugs.

"We started the company in anticipation of this new niche of generic versions of biotech drugs opening," said Thomas Flynn III, Therapeutic Proteins' chief executive. Flynn expects Therapeutic Proteins to make its first biogenerics for the U.S. market in two to three years. "The newly enacted health care bill removed the main hurdle in the promulgation of a bill in Congress to allow biological drugs to be sold as generics," Flynn said.

The eventual introduction of cheaper biotech drugs in the U.S. could save $10 billion a year once biogenerics are on the market here, according to some estimates. Patients generally see a 20% to 30% savings in biogenerics over name-brand drugs.  Some countries are already reaping substantial savings. For example, Lake Forest-based generic biotech drug producer Hospira Inc. said it already is selling its drug Retacrit, a biosimilar version of Epogen, in Europe.

”We are thrilled to have TPI as an anchor tenant as their business and operations acumen will be very beneficial for the developing and emerging biotech companies not only at the UTP at IIT, but also for Chicago and the Midwest,” said David Baker, Executive Director, University Technology Park. “It shows the world that Chicago is a developing hub for life-improving therapeutic agents that will serve to lower health care costs and improve the lives of many in need."

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