E-drug: Time needed to provide bioequivalence studies (cont'd)
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[We already had a response on bioequivalence studies in South
Africa, but below is a more detailed description. Thanks Esthi! HH]
A bio-equivalence study should be finalised within 6-9 months.
However, delays are frequent.
Very costly in South Africa; about R 400,000 (9,37 Rands per
US$). This would be for say a 14 patient randomised cross-over
study. Please note that each product is different and different tests
are performed on each product (this is determined by the side-effect
profile, data management, laboratory tests, validations of the
assays, etc). So, for example a ciprofloxacin 14 patient study
could cost R 400,000 and a 14 patient nifedipine study could
cost R 500,000. Price is also determined by the number of patients
used in each trial. The number of patients for a slow-release
preparation will be a minimum of 24 - as specified by the Medicines
Control Council. At present our Medicines Control Council is
rewriting their guidelines on bioequivalence studies.
To register a product a company would have to develop their
product and then do stability tests to ensure the product is stable.
The company would also need to do a bio-equivalence study to
ensure that their generic is bio-equivalent to the innovator. If the
outcomes of these studies are positive, a registration application
may be submitted to the Medicines Control Council. At present our
MCC is understaffed and overworked and therefore if your data is
acceptable to the MCC you might have a registration in 2 to 3
years.
Once a company has gone to all expense to have a stable
bio-equivalent generic, they can market their product in South
Africa. Currently most drugs that are off patent have 2-5 generics
on the market. If you were to share your bio-equivalence with
everyone you would be losing market share and most important: are
you sure that their formula is identical to yours? If not then the
other product is obviously not bio-equivalent to the innovator. We
have seen that even small changes in the amount of inactives cause
large changes in certain medicines bio-equivalence. Certain
medicines are narrow therapeutic drug and small changes can have
large effects on the patient.
I hope I have been of some help.
Kind regards,
Esthi Beukes
Pharmacist
Clindev
South Africa
e-mail: biodev@mweb.co.za
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