Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Me too drug

5,983 views

Published on

Me-too drugs are products which largely duplicate the action
of existing drugs.

Published in: Health & Medicine
  • Be the first to comment

Me too drug

  1. 1. Me-Too Drugs (“follow-on” drugs) DR SUYASH BHARAT PG JR 3rd Pharmacology
  2. 2. DEFINATION • A drug that is structurally very similar to already known drugs, with only minor differences. The term "me-too" carries a negative connotation. However, me-too products may create competition and drive prices down. • (also called “follow-on” drugs) • Me-too drugs can be broadly defined as chemically related to the prototype, or other chemical compounds which have an identical mechanism of action.
  3. 3. • The key problem with me-too drugs is that, to the extent that they are similar to pre-existing drugs, they diminish the incentives for innovation in pioneering drugs without adding therapeutic value. • Me-too drugs also absorb R&D resources, which is wasteful if they are undifferentiated from pre-existing drugs.
  4. 4. • On the other hand, the more differentiated me- too drugs are from pioneering drugs, the greater their potential benefits, and the less they harm the incentives for pioneering research. • Defined very narrowly as drugs which have more or less identical clinical outcomes to pre-existing drugs, me-too drugs are likely of little value – indeed in this case they effectively undermine the intent of patent protection, without even providing much benefit from price competition.
  5. 5. Benefits of me-too drugs • Some follow-on drugs are better than the pioneer drug • increased choice between drugs  pioneer drug is ineffective or entails undesirable side effects • led to substantial price reductions
  6. 6. Costs of me-too drugs 1. me-too drugs reduce the incentive to undertake pioneering innovation. 2. me-too drugs may have an unacceptable benefit/risk ratio, if their incremental benefits are relatively small. 3. me-too drugs may be using up more resources than they are worth.
  7. 7. Me-Too vs. First-In-Class Drugs • First-in-class drugs are novel drugs. • Me-too drugs are similar, related drugs to first-in-class drugs. • Marketing may exaggerate the benefits of a me-too drug versus the original first-in-class drug. • Me-too products may create competition and drive prices down.
  8. 8. • A me-too drug could be better than a first-in-class drug, or it could be worse. • Example: • Simvastatin, a me-too drug, is a more effective statin than lovastatin, a first-in-class drug. • On the other hand, Baycol (cerivastatin) was withdrawn from the market due to a disproportionate number of cases of rhabdomyolysis. Graphic reprinted by permission from Pill Advised.
  9. 9. BAYCOL WAS WITHDRAWN FROM THE MARKET IN AUGUST 2001 DUE TO EXCESS CASES OF RHABDOMYOLYSIS.
  10. 10. Me-Too Drugs: Marketing Messages 1. Increased potency or longer duration of effect 2. Faster onset of action 3. Fewer unwanted effects 4. Improved receptor selectivity • Conversely, first-in-class drugs may market their longer history and larger body of research
  11. 11. 1. Increased Potency or Longer Duration of Effect • May add no clinical benefit • May increase the risk of adverse events • May increase flexibility in dosing options
  12. 12. 2. Faster Onset of Action •In chronically used drugs, such as statins, faster onset of action would only affect the first dose.
  13. 13. 3. Fewer Unwanted Effects • Unwanted effects take time to be discovered and reported. • Pre-market studies cannot pick up long- term adverse effects, drug interactions, or effects that occur only in elders, diabetics, or other subpopulations. • Claims of increased safety for new drugs are not trustable without long-term data.
  14. 14. 4. Decreased Risk for Drug Interactions Molecular stories, such as improved receptor selectivity, may not necessarily have a clinical benefit.
  15. 15. To properly assess a me-too drug, adequate controlled studies with patient-oriented endpoints in relevant populations are required.
  16. 16. THANK YOU • Ask yourself: Does treatment with the me- too drug result in the patient living longer or better?
  17. 17. Reference • Aidan Hollis. Me-too drugs: is there a problem?Department of EconomicsUniversity of Calgary.December 2004

×