http://pilladvised.com/wp-content/uploads/2011/04/risks-benefits.jpg Graphic reprinted by permission from Jonathan Galland, CEO Pill Advised
Me too drug
Me-Too Drugs (“follow-on”
DR SUYASH BHARAT
PG JR 3rd Pharmacology
• 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.
• 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.
• 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.
Benefits of me-too drugs
• Some follow-on drugs are better than the
• increased choice between drugs pioneer
drug is ineffective or entails undesirable side
• led to substantial price reductions
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.
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
• Me-too products may create
competition and drive prices down.
• A me-too drug could be better than a first-in-class drug, or it
could be worse.
• 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• On the other hand, Baycol (cerivastatin) was withdrawn from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
Graphic reprinted by permission from Pill Advised.
BAYCOL WAS WITHDRAWN
FROM THE MARKET IN
AUGUST 2001 DUE TO
EXCESS CASES OF
1. Increased potency or longer duration of
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
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
2. Faster Onset of Action
•In chronically used drugs, such as statins,
faster onset of action would only affect the
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.
4. Decreased Risk for
Molecular stories, such as improved receptor
selectivity, may not necessarily have a clinical
To properly assess a me-too drug, adequate
controlled studies with patient-oriented
endpoints in relevant populations are
• Ask yourself: Does treatment with the me-
too drug result in the patient living longer or
• Aidan Hollis. Me-too drugs: is there a
problem?Department of EconomicsUniversity
of Calgary.December 2004