Bioequivalence and Bioavailability Forum

3.2 When bioequivalence studies are not necessary
In following formulations and circumstances, bioequivalence between a new drug and the reference product may be considered self-evident with no further requirement for documentation:
a. When new drugs are to be administered parenterally (e.g., intravenous, intramuscular, subcutaneous, intrathecal administration etc.) as aqueous solutions and contain the same active substance(s) in the same concentration and the same excipients in comparable concentrations;

5.1.6 Parenteral solutions
The applicant is not required to submit a bioequivalence study if the product is to be administered as an aqueous intravenous solution containing the same active substance in the same concentration as the currently authorised product.
In the case of other parenteral routes, e.g. intramuscular or subcutaneous, if the product is of the same type of solution (aqueous or oily), contains the same concentration of the same active substance and the same or comparable excipients as the medicinal product currently approved, then bioequivalence testing is not required.