A seminar dedicated to the issues of bioequivalence and comparative pharmacokinetic studies was held at the State Expert Center.
The goal is to deepen applicants' systemic understanding of the principles of proving bioequivalence and conducting comparative pharmacokinetic studies in accordance with current national and international regulatory requirements – this will improve the quality of dossier preparation in terms of proving bioequivalence.
Well-conducted studies are a guarantee that a more affordable generic medicinal product will be safe and as effective as the reference product.
To prove bioequivalence, comparative pharmacokinetic studies or the biowaiver procedure based on the Biopharmaceutics Classification System (BCS) are used.
During the training, participants became familiar with:
- the current regulatory framework governing the processes of bioavailability and bioequivalence in Ukraine and worldwide;
- criteria to pay attention to when conducting comparative pharmacokinetic studies in accordance with the guideline "Medicinal products. Bioequivalence studies" (Ukraine, 2022) and the new EMA ICH M13A guideline (2025);
- methods of demonstrating bioequivalence depending on the medicinal form and route of administration, as well as the conditions under which bioequivalence studies may not be conducted;
- approaches to selecting the reference product;
- information on conducting and assessing the validity of the bioanalytical part of a pharmacokinetic study in accordance with the requirements of the ICH M10 guideline.
The seminar speakers paid particular attention to the harmonization of ICH international guidelines in Ukraine. They pointed out the differences between the current version of ICH M9, implemented in Ukraine, M10 (the draft is under approval at the MoH) and M13, which is in force in the EU and is important for those pharmaceutical companies planning to register medicines on the European market.
As a consolidation exercise, they analysed a number of typical errors often made by applicants when substantiating the proof of bioequivalence in registration documents, examined complex cases from practice, and provided answers to questions.
The training was conducted by specialists of the Department for Assessment of Bioavailability and Equivalence of the Center, Nadiia Zhukova and Oksana Nahorniak. The event was coordinated by the Head of the Agency for Methodological and Scientific-Practical Work, Oleksandr Hudzenko.
The knowledge gained will allow developers of medicinal products to:
- improve the quality of studies and minimise risks in demonstrating the similarity of a generic product to the original medicinal product
- avoid typical mistakes in the dossier that become grounds for the regulator's refusal during registration
- guarantee the proper quality, efficacy and safety of medicines entering the Ukrainian market.
For more about the Center's planned training sessions for the current 2026 year, see the link https://surl.lt/sqezdp
