Drug Topics - September 22, 2008 - (Page 4) 4 DRUG TOPICS Sept. 22, 2008 www.drugtopics.com Of Interest to Pharmacists ture of the FDA, we’ve had very good success selling our idea in Washington. Within that pathway, there are two other issues. One is BIO’s insistence that the legislation mandate clinical trials. Our position is that FDA should control the scientific effort. That’s how things work now and that’s how things should work in the future. The second issue is whether these products will be substitutable. Substitutability should be left up to the FDA. We are advocating for the model that is already in existence in the United States. There also needs to be a mechanism to resolve intellectual property disputes prior to product launch. BIO wants a much broader, more cumbersome, slower, deliberate, lengthy process. We want a process that is capable of being resolved in a timely fashion so as not to delay launch. in the fifth year as other competitors enter the market. For example, this year Medicare Part B will spend close Kathleen Jaeger to $2 billion on just the biologic anemia drug Epogen (epoetin, Amgen), an amount approximately equal to the FDA’s entire FY 2008 budget. Saving even 25 percent would lower Medicare’s drug expenditures by $625 million. According to IMS Health, generic prescription volume is continuing to grow, as is the industry as well, although at a slower pace than in previous years. Generics are also gaining ground in the top five pharmaceutical classes. Between now and 2012, more than $60 billion Kathleen Jaeger President and CEO Generic Pharmaceutical Association The FDA has stated that it has the scientific ability to review and approve biogenerics. Now it needs the authority. The market for biopharmaceuticals is growing at more than twice the rate of traditional drugs. Annual U.S. sales of biologics are projected to hit $100 billion in three years and account for more than one-fourth of total drug spending. Biogenerics can make those treatments more accessible for patients. Biogenerics are expected to enter the U.S. market at costs of 10 to 25 percent less than brands, increasing to a range of 25 to 47 percent http://www.drugtopics.com http://www.watson.com
Table of Contents Feed for the Digital Edition of Drug Topics - September 22, 2008 Drug Topics - September 22, 2008 Contents Generics Executives Look Ahead to 2009 Congress Still Working on Biologic Generics Bill Drug Topics - September 22, 2008 Drug Topics - September 22, 2008 - Contents (Page 1) Drug Topics - September 22, 2008 - Contents (Page 2) Drug Topics - September 22, 2008 - Generics Executives Look Ahead to 2009 (Page 3) Drug Topics - September 22, 2008 - Generics Executives Look Ahead to 2009 (Page 4) Drug Topics - September 22, 2008 - Generics Executives Look Ahead to 2009 (Page 5) Drug Topics - September 22, 2008 - Congress Still Working on Biologic Generics Bill (Page 6)
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