BIOSTATISTIC, LEGISLATIV AND ETHICAL PROBLEMS OF
COMPARATIVE CLINICAL STUDIES. I. GENERIC AND BIOSIMILAR
DRUGS CASE
RALUCA GAVRILĂ 1, MONICA ISAILĂ 2,4, CONSTANTIN MIRCIOIU 1,4, FLORENTINA GHERGHICEANU 1, ISABEL GHIȚĂ 1, IRINA PRASACU 1*, ION MIRCIOIU 3
1”Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
2Ministry of Health, Juridical Department, Bucharest, Romania
3Medicient SRL, Bucharest, Romania
4National Commission of Bioethics of Drugs and Medical Devices, Bucharest, Romania
*corresponding author: irinaprasacu@yahoo.com
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Abstract:
This paper presents an ethical approach of the clinical studies, biostatistical and legislative aspects for testing generics and
biosimilars and the valuation of the obtained results in clinical practice and health politics. Both generics and biosimilars are
considered as alternative treatments contributing essentially to ensure the human right to health, cost and life savings for
large populations. In case of generics, interchangeability is accepted practically in all countries. An ethical direction more to
be considered in the future is the biowaiver of the in vivo bioequivalence clinical trials based on in vitro dissolution studies
and knowledge concerning the in vitro - in vivo correlations. Population and individual bioequivalence as alternative to
average bioequivalence are considered non-ethical in the context of risk-benefit balance in bioequivalence studies concerning
generics, but could be further considered in case of biosimilars. This paper makes a comparative analysis of the regulations in
different countries concerning prescribability and interchangeability of biosimilars. The conclusion of the authors is that
prescribability is perfect by applicable in both cases of generics and biosimilar drugs. Interchangeability is considered
applicable in case of generics and desired in case of biosimilars but mainly after establishing the appropriate biostatistical
methods for the design of the corresponding bioequivalence clinical trials and analysis of results.






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