Branded medicines undergo a rigorous
process of clinical trials assessing safety and
effectiveness before they are approved for
human use.
However, generic medicines can
be approved on the basis of
pharmacokinetic studies carried out on a
minimal number of healthy volunteers,
Generic medicines have the same active
ingredient as the branded medicine.
However, they are not always identical to
the branded medicine.
The amount of drug that finally reaches the site of action is
known as the ‘bioavailability’.
Thebioavailability is very important, because
this will determine how effective the
medicine will be. Too little drug reaching
the target could lead to less effective
treatment, but too much could increase side
effects. The bioavailability can vary between
branded and generic medicines, and
between different generic medicines, with
the same amount of active ingredient. This
is because the formulation and excipients
(other ingredients included in the medicine)
affect the absorption and metabolism of the
drug.
where they are shown to be ‘bioequivalent’
to the branded medicine. This means that
the rate and extent of their bioavailability
lies within ‘acceptable predefined limits’
compared with the original branded
medicine. For a generic medicine to be
considered bioequivalent, the European
Medicines Agency (EMEA) requires the
measures of bioavailability (area under the
curve and Cmax) to be within 0.8 and 1.25 of
the original medicine’s values.
Thus, the relative bioavailability of the generic
medicine can lie anywhere between 80%
and 125% of the original medicine’s values.
Bearing in mind that patients can be
switched with each prescription
Patients with certain conditions requiring
carefully balanced combinations of
medications would also be
disproportionately affected by medicine
substitutions. For example, people with
Parkinson’s disease often take a
combination of medications, which must be
taken at the correct time for them to avoid
worsening of their symptoms. Patients
with Parkinson’s disease could be
understandably concerned about apparent
changes in their medication. In addition,
changes in formulation type could affect
symptom control