According to the recent FDA data,
the term generic has to be clarified in that there are
3 types of drugs in the market:
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Original
drugs: either on or off patent |
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Generic
products with bioequivalent studies to the
original (100%bioequivalent true generics) either
carrying a brand name or international non proprietary
name INN |
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Copies:
products without bioequivalent studies to the
original (not bioequivalent and so called copycats
or me too products) |
A
generic drug as defined by the US FDA is:
Identical
or bioequivalent to a brand name drug in dosage form,
safety, strengths, route of administration, quality,
performance characteristics and intended use
NB. Since generics contain well known safe and effective
substances, preclinical tests and clinical trials can
be replaced by bioequivalent studies
‘All Ranbaxy products are true generics with
approved bioequivalent studies to the innovators with
patency on the manufacturing techniques in many cases’
Generic business for medicines
is expanding worldwide and represents a true valuable
alternative to patients. The EU generic market today
is worth 7 billion euros out of 70 billion total market.
Many of the world's industrialized countries have implemented
policies that encourage the use of generic medicines.
As a result generics currently account for over 40%
of total pharmaceutical sales by volume in USA, Canada,
Denmark, and UK
(Source World Bank, respective ministries of health;
IMS health 2003)
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