Corresponding author. Received Nov 20; Accepted Jan We would like to comment on an interesting review article on the similarities and differences among international guidelines for determining bioequivalence BE of generic drug products 1. Because the legal framework of the Brazilian Health Surveillance Agency ANVISA is available only in Portuguese, it might have been difficult to search information properly or to identify updated guidelines. In this context, we would like to clarify some misunderstood definitions. Whatever is not mentioned here is correctly stated in the article.
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Corresponding author. Received May 21; Accepted Jun According to Resolutions RE n. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over —, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products. KEY WORDS: bioequivalence, generic, topic In this note, we would like to comment a recently published review article on the similarities and differences among some international jurisdictions in accepting bioequivalence approaches for generic topical dermatological drug products [ 1 ].
The current guideline describes how pharmacokinetics tests should be performed for those medicines requiring a demonstration of blood level bioequivalence and, in cases where it is not possible to precisely and accurately quantify the drug in circulation, when pharmacodynamic measurements may be accepted.
Resolution RE n. In spite of the mention of such pharmacodynamic tests, they are not required for topical dermatological drug product approval, as suggested in Tables II and III of the aforementioned review. Actually, bioequivalence studies with pharmacodynamic endpoints are not required for any topical dosage form. According to the Resolution RDC n. Therefore, only in vitro studies are required for registration of all generic topical dermatological drug products, including those containing corticosteroids.
Consideration for equivalence includes formulation general aspect, pH, viscosity, density, drug active concentration assay, and microbiological tests results [ 4 ]. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over —, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products [ 5 ].
Nonetheless, only the post-approval guidance RDC48, of October 6th , has mentioned the need to assess the drug permeability of topical dermatological products, although this guidance has not specified the experimental procedures to be followed [ 6 ].
In revision process of Resolution , ANVISA is considering the need to require additional tests as supportive evidences for safety and efficacy of these products. Bioequivalence approaches such as in vitro release tests, in vitro skin permeation tests, dermatopharmacokinetic studies, and in vivo pharmacodynamic studies for corticosteroids, which are the most common therapeutic class of topical dermatological drug products in Brazil [ 7 ], may be included as requirements in the future.
In the continuous process of revising and updating regulatory recommendations, it is essential that international regulatory authorities and organizations share their experiences. Successful approaches implemented internationally could lead to a global alignment in regulatory requirements and would improve the efficacy of topically administered generic formulations. References 1. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.
AAPS J. Brazilian Health Surveillance Agency. Accessed 5 May Provides information about pharmaceutical equivalence determination and dissolution profile comparison. Provides information about alteration, inclusion, suspension, reactivation, cancelation post approval of medicines.
Bioequivalence of dermatological topical medicines: the Brazilian scenario and the health surveillance challenges. Accepted in February, 29th,
Bioequivalence and Bioavailability Forum