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Plasma Protein Therapies Not Suitable for Biosimilars
Date:11/12/2010

interchangeable with a biosimilar version of the therapy.  

PPTA is a global trade association that represents source plasma collectors and manufacturers of plasma protein therapies including blood clotting factors that treat bleeding disorders; immune globulins that bolster or supplant a failed immune system; alpha-1 proteinase inhibitors, which treat genetic chronic obstructive pulmonary disease (COPD); and albumin, which is used in critical care settings to treat severe trauma and burns and during surgery.

While Congress debated the federal health reform legislation, the Association commissioned a white paper to evaluate the impact biosimilars would have on patient care, concluding it would put the health of fragile patient populations at increased risk of developing complications. "The bottom line is that science and precedent do not support a biosimilar approach for plasma protein therapies, and protecting access to safe and effective treatment should remain the first priority," said Julie Birkofer, Senior Vice President, PPTA North America.

The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies and the collectors of source plasma. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions including hemophilia, primary immunodeficiency diseases and alpha-1 antitrypsin deficiency. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today and more than 60 percent worldwide. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein th
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SOURCE Plasma Protein Therapeutics Association (PPTA)
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