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Me too drugs
110
Me-too Drugs
Presentation For Drug Design
Introduction
Introduction
Me-too drugs can be broadly defined as chemically related to the prototype, or other chemical compounds which have an identical mechanism of action.
This increasing marketing of me-too drugs has been questioned, so pharmaceutical firms are justifying the development of not-so-innovative drugs.
Benefits
Benefits
• 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
Costs of Me-too Drugs
Disadvantage
• me-too drugs reduce the incentive to
undertake pioneering innovation.
• me-too drugs may have an unacceptable
benefit/risk ratio, if their incremental
benefits are relatively small.
• me-too drugs may be using up more
resources than they are worth.
Marketing Messages
1. Increased potency or longer duration of effect
Marketing Messages
2. Faster onset of action
3. Fewer unwanted effects
4. Improved receptor selectivity
Marketing messages
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
Marketing messages
2. Faster Onset of Action
•In chronically used drugs, such as statins,
faster onset of action would only affect the
first dose
Marketing messages
3. Fewer Unwanted Effects
• Unwanted effects take time to be discovered and reported.
• Pre-market studies cannot pick up longterm 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.
Marketing messages
4. Decreased Risk for Drug Interactions
Molecular stories, such as improved receptor
selectivity, may not necessarily have a clinical
benefit.
Example
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• On the other hand, Baycol (cerivastatin) was withdrawn from the market due to a disproportionate number of cases of rhabdomyolysis.
Reference
Aidan Hollis. Me-too drugs: is there a
problem?Department of EconomicsUniversity
of Calgary.December 2004