Processing Magazine

Panel backs 12-year biotech drug shelter

August 3, 2009
Under a proposal adopted by a key House committee, Biotech drugs would be protected from competition from cheaper rivals for 12 years, reported by Reuters. The 47-11 vote in the House Energy and Commerce Committee is a major win for biotech drugmakers such as Amgen and Roche Holding and other brand name traditional drugmakers looking to get into the field. Manufacturers of brand-name biotech drugs have been pushing for a period of 12 to 14 years before generic copies of their medicines can win approval. Generic drugmakers, consumer groups and their allies are pushing for a 5 to 7 year period. Rep. Anna Eshoo, the California Democrat who sponsored the proposal, said the measure would save $9 billion over 10 years. The amendment passed as part of massive health reform legislation winding its way through both chambers of Congress. The Senate health committee earlier this month backed 12 years of protection. The amendment would allow U.S. health regulators for the first time to approve potentially cheaper versions of complex biologic drugs. In exchange, brand companies would get 12 years of protection from generic competition first.