Bioequivalence and Bioavailability Forum

❝ However, EMEA allows suprabioavailable drugs in some cases but with

❝ different labelling.

If suprabioavailability is found, i.e. if the new product displays an extent of absorption appreciably larger than the approved product, reformulation to a lower dosage strength should be considered. In this case, the biopharmaceutical development should be reported and a final comparative bioavailability study of the reformulated new product with the old approved product should be submitted.
In case reformulation is not carried out the dosage recommendations for the suprabioavailable product will have to be supported by clinical studies. Such a pharmaceutical product should not be accepted as therapeutically equivalent to the existing reference product. If marketing authorisation is obtained, the new product may be considered as a new medicinal product.
To avoid confusion for both prescribers and patients, it is recommended that the name of suprabioavailable product precludes confusion with the older approved product Suprabioavailable products cannot claim "essential similarity" (see section 2.5) with the innovator product.   (my emphases)