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Generics poised to ride wave
of branded patent expirations
These countries each have a strong medical infrastructure, for generics
cheaper manufacturing and labor, and an ease of recruiting legislation
Generics account for 60 percent of prescriptions, and patients with diseases for clinical trials. In the case of India, the industry is poised to benefit from an unprecedented English also is predominant, negating the language barrier. and prolonged wave of branded drugs coming off patent.
And there are other advantages: Much of these coun- A growing global market is creating opportunities for tries’ populations are still very low-income, unable to Drug Store News: What are the Generic Pharma-
generics, while at the same time the U.S. pharmaceutical afford branded pharmaceuticals even if they are available.
ceutical Association’s goals for the coming year? industry wrestles with the issue of biogenerics.
And Western habits are starting to infiltrate on a broad Biosimilars (also known as biogenerics and follow-on bio- basis. This means that along with a proliferation of fast- Jaeger: We’ve had an extremely busy and pro-
logics) are gathering speed in Europe, with the most recent food chains, there also are more cars, video games and ductive year, and we anticipate that our agenda being approved late this summer. This means there now are cigarettes, all of which add up to nations with a greater will be full in 2008 as well. Overall, our goal will four biosimilars available in Europe—three versions of John- obesity problem and all the diseases that accompany it.
be to continue to increase consumer access to son & Johnson’s anemia blockbuster Eprex, from companies This news is good news for generic drug makers, and safe, effective and affordable generics. This Sandoz, Hexal Biotech and Medice Arzneimittel Putter, and by 2010 foreign drug manufacturers could control half of means we will be building on our successful human growth hormone Omnitrope, from Sandoz, which China’s pharmaceutical market, according to estimates efforts to move legislation forward to establish a approval pathway for biogenerics, working to put Unbranded generics are gaining traction
an end to the practice of authorized generics, % Dollars
% Total prescriptions dispensed
acting to increase funding for the FDA’s Office of Generic Drugs and advancing legislation to address industry concerns with the Centers for Medicare and Medicaid Services’ new phar- macy reimbursement rule. We also anticipate that congressional consideration will continue next year on pending legislation, including patent reform, patent settlements, anticounterfeiting/ pedigree issues and free trade agreements.
DrSN: There has been a lot of talk about
authorized generics in the past year. What is the outlook for them, and how are they affect- Jaeger: When the Hatch-Waxman Act was cre-
ated, Congress wisely granted a 180-day period of exclusivity to generic companies to spark competition and increase the availability of safe 2001 2002
2003 2004 2005 2006
2001 2002
2003 2004 2005 2006
and affordable generics. However, brand com- panies are increasingly deciding to circumvent congressional intent by bringing authorized Unbranded generics
Branded generics
generics to market during the 180-day period.
Source: IMS NPA Plus, IMS National Sales PerspectivesTM, December 2006 This blatant move to cut the legs out from under congressional intent only serves to harm con- According to Waxman: “The uniqueness of biological While keeping an eye on these emerging markets, U.S.
sumers by stifling competition. Some members products suggests only a case-by-case approach for evalu- generic drug firms also should be keeping check on the of Congress are taking action to close this loop- ating each type of product. We can’t afford to wait for a hole. Sen. John Rockefeller, [D-W.Va.], and These should be profitable times for generic drug mak- Rep. JoAnn Emerson, [R-Mo.], have introduced Biogeneric drug makers, together with a number of sen- ers. Generic drugs accounted for 60 percent of total drugs legislation to block authorized generics from ators and Waxman, have been pushing legislation for the dispensed in 2006, and upcoming patent expirations make being marketed during the 180-day period. We Food and Drug Administration to create a pathway to this the “golden age” of generics, said Ed Pezalla, vice strongly support that legislation and will work approve biogeneric drugs. However, it’s now “extremely president and medical director of Prescription Solutions, with its co-sponsors to help move the legislation slim” that this will be added to a broader FDA bill that is at the Pharmaceutical Care Management Association’s now moving through Congress, Waxman said earlier this Pharmacy Benefit Management & Generic Pharmaceutical month. He added, however, that he was hopeful a generic DrSN: Four biosimilars have been approved in
biologics bill would pass before the current Congress “We’re just starting off on the biggest period of patent Europe, and legislation is attempting to push expirations we’ve ever seen,” said Barath Shankar, them through here. What do you expect to see The U.S. generics industry also should keep its eyes on research analyst with Frost & Sullivan. And it’s not both India and China, two countries that are expected to something that’s going to end, he added, but there’s become pharmaceutical powerhouses in the next 10 years.
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September 24, 2007 • 29
DRSN_092407_p36,39 9/11/07 7:24 PM Page 39 response to Pfizer’s Xanax (alprazolam) launches as generic Xanax and Seasonale.
istration. Annual sales for all strengths Funding at the FDA’s
Generics poised and they are increasing. In the Office of Generic Drugs
Citizens’ Petitions
Authorized generics
t o l a u n c h a t t h e e n d o f (Abbott), Advair (GSK), n a t e , w h i c h i s e x p e c t e d amax (Merck), Depakote Drug Store News
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September 24, 2007 • 39

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