Drug Topics - September 22, 2008 - (Page 3) DRUG TOPICS 3 Of Interest to Pharmacists Generics executives look ahead to 2009 raditionally, generics industry executives are tight-lipped about their business plans. But Drug Topics managed to corral five industry leaders who opened up about their hopes, fears, and challenges: Fred Gebhart T be the impact. It’s of concern to us. Douglas Boothe Executive Vice President Actavis Inc. Everyone is talking about a [regulatory] pathway to bring generic equivalents to biologics to the United States. There is a lot of discussion around new ways of looking at reimbursement metrics and AMP. Generics will be best positioned, given the value proposition that we offer to our customers and ultimately to consumers. But change creates uncertainty. There are winners and losers. Another issue is industry consolidation. The big three wholesalers continue to get bigger, and the larger buyers are getting bigger. If there are fewer people to sell to, the balance of power gets out of kilter. The U.S. generics space is still a very attractive market, but that is under challenge. People who filed ANDAs (abbreviated new drug applications), thinking it’s an easy road to make money, are finding it’s a lot more challenging. Patent expirations are not a recipe for success for true generics companies. If you wait for the patent to expire, you are probably 97th in line. A key for us and our good competitors is challenging patents or getting a good formulation through a noninfringement route. But the easy stuff has already been picked over. In the longer term, our pipeline is the brand pipeline. Right now, a lot of the brand activity is around biologics. Roughly two-thirds of the new NMEs (new molecular entities) filed recently have been biologics. To the extent to which there is not a biogenerics pathway, that pipeline will dry up. We’re a long way from that, but it’s a very real threat. Paul Bisaro CEO Watson Pharmaceuticals The top challenge is generic biologics and having a pathway [to approval]. We believe that it’s the future and, without that pathway, we are not going to have the opportunity. The next challenge would be to recognize that the Food and Drug Administration (FDA) is understaffed and underfunded. There are more generics companies than ever filing applications, and there is a wide disparity between the quality of the applications. Everybody is being affected by the speed of approvals. The solution is a combination of more funding and perhaps a good fee-for-use program, but the FDA is also taking a hard look at its practices. If all three of these things happen, our industry will be in good shape. Pending average manufacturer price (AMP) legislation has the potential to impact the way generics prices are set in ways that people haven’t really thought about. Say 12 people get approval on any particular drug. Some number of those 12 are going to sell the product below their cost of manufacture, then stop selling the product. But there is no recognition of that in the current legislation. You have an AMP that is set below the cost of manufacture. That was not what was intended but could Bruce Downey President and CEO Barr Laboratories The seminal event I Paul Bisaro would expect over the next two years is passage of generic biologics legislation. The momentum is behind us in Congress. Both Senators McCain and Obama have campaign positions favoring this kind of legislation. The BIO (Biotechnol- Douglas Boothe ogy Industry Organization) industry wants a guidance-driven process in which the FDA has public notice and comment for draft guidances, revised draft guidances, and guidances that specify the scientific approach for every protein Bruce Downey for every indication. Our idea is that the pathway should be sponsor-driven and FDA-controlled, just like with BLAs (biologics license applications), NDAs (new drug applications), and ANDAs. The sponsor goes to FDA with a biogeneric IND (investigational new drug) or the equivalent, FDA comments on the protocol, you make adjustments based on their comments. Given the structure of the industry and the struc-
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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