How many "me-too" drugs is too many?

@article{Gagne2011HowM,
  title={How many "me-too" drugs is too many?},
  author={Joshua J Gagne and Niteesh K. Choudhry},
  journal={JAMA},
  year={2011},
  volume={305 7},
  pages={
          711-2
        }
}
ON AUGUST 3, 2009, THE US FOOD AND DRUG ADministration (FDA) approved pitavastatin (Livalo), making it the eighth statin approved for use in the United States and seventh currently available for sale. This approval comes almost a quarter century after that for the first member of the class, lovastatin, 8 years after generic lovastatin was approved and 4 years after 2 additional statins, pravastatin and simvastatin, lost patent protection and generic versions of them entered the market. “Me-too… 
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Sample closet medications have limited novelty and usefulness and are often expensive, so the widespread use of sample medications should be reexamined.
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It was found that TJSI can detect the difference between follow-on drugs with distinguishing features and those without them better than the other publication indices (AJI or RCT) and could be useful for the assessment of situations with multiple market entrants in the same class when a new addition has a questionable value.
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References

SHOWING 1-10 OF 12 REFERENCES
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.
TLDR
Clinical evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, and a substantial number of editorials counsel against the interchangeability of generic drugs.
Copayment levels and medication adherence: less is more.
TLDR
Nonadherence is a central reason why many patients do not achieve their low-density lipoprotein goals and patients who are nonadherent have worse clinical outcomes and higher healthcare costs than their adherent counterparts.
Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
TLDR
Among patients who have recently had an acute coronary syndrome, an intensive lipid-lowering statin regimen provides greater protection against death or major cardiovascular events than does a standard regimen.
Prescription drugs and managed care: can 'free-market détente' hold?
  • D. Moran
  • Political Science, Medicine
    Health affairs
  • 2000
TLDR
There is evidence that this private-sector détente may give way in the face of the rising business and political pressures that both industries face, and active leadership will be required to prevent deterioration of the prevailing political climate toward economic controls.
Medical decision making in situations that offer multiple alternatives.
TLDR
In one scenario involving a patient with osteoarthritis, family physicians were less likely to prescribe a medication when deciding between two medications than when deciding about only one medication and the difficulty in deciding between the two medications led some physicians to recommend not starting either.
Livalo Launch Press Release (PDF). http://www.lilly.com/news /kits/livalo
  • Accessed November
  • 2010
and Drug Administration
  • FY 2009 PDUFA Financial Report: Total Costs of the Process for the Review of Human Drug Applications: October 2010. http: //www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports /FinancialReports/PDUFA/ucm226688.htm. Accessed November 15,
  • 2010
Potential Savings From Substituting Generic Drugs for Brand-Name Drugs: Medical Expenditure Panel Survey, 1997-2000Haas JS, Phillips KA, Gerstenberger EP, et al (Brigham and Women's Hosp, Boston; Univ of California, San Francisco) Ann Intern Med 142:891–897, 2005§
El tratamiento hipolipemiante intensivo frente al moderado con estatinas tras síndromes coronarios agudos
  • 2004
Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
...
1
2
...