ANNAPOLIS, Md., Nov. 12, 2010 /PRNewswire/ -- The current science and experience does not support the safety and efficaciousness of a biosimilar pathway for plasma protein therapies. At a public hearing last week, the Plasma Protein Therapeutics Association (PPTA) urged the United States Food and Drug Administration (FDA) to make patient safety its top priority by adopting a global approach in its evaluation of plasma protein therapies for the biosimilars process. The hearing sought to obtain input from stakeholders prior to FDA's implementation of the Biologics Price Competition and Innovation Act of 2009, which was part of the new health care reform law.
Plasma-derived therapies and their recombinant DNA technology analogs, collectively known as plasma protein therapies, treat extremely rare, chronic and life-threatening diseases and disorders, including alpha-1 proteinase inhibitor deficiency, hemophilia and primary immune deficiency diseases. At the FDA hearing, PPTA called for harmonization with European Medicines Agency (EMA) guidelines with regard to therapeutic class exceptions for plasma protein therapies.
Under new U.S. federal law, FDA is empowered to exclude a specific product or an entire therapeutic class from the biosimilars process based on the current science and experience. The new law, however, expressly prohibits FDA from using that same rationale to exempt recombinant proteins, including blood clotting factors used to treat hemophilia and other bleeding disorders. This recombinant protein provision runs counter to the precedent established by the EMA in its 2005 guideline that exempts certain plasma protein therapies, including recombinant blood clotting factors, from the biosimilar process in the European Union. Specifically, if a manufacturer of a biological product is seeking approval as a biosimilar by referencing a brand of immune globulin or blood clotting factor (either plasma-derived or recombinant), the EMA guidelines
|SOURCE Plasma Protein Therapeutics Association (PPTA)|
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