Original and reproduced medicinal products: are they comparable? Emphasis on moxonidine

A.P. Pereverzev

Russian Medical Academy of Continuous Professional Education, Moscow

Nowadays, life expectancy worldwide is growing and, according to the World Health Organization, the number of people over 60 will double by 2050. With increasing life expectancy, the number of patients with arterial hypertension increases, which leads to the need for antihypertensive drugs with moxonidine.

A medicinal product (MP) with a new active substance, which is the 1st registered and approved in clinical practice based on the preclinical and clinical study results confirming its quality, efficacy and safety, is called an original MP. After the expiration of the patent protection period, any pharmaceutical companies receive the right to manufacture and sell MPs equivalent to the original in terms of the qualitative and quantitative composition of active substances, as well as an equivalent dosage form (reproduced MPs, generics). To register the MP data, it is sufficient to conduct bioequivalence studies, i.e. confirmation of pharmacokinetic parameters comparable to the original MP in the same dosages and administration method. The article considers the differences between the original and reproduced MPs due to the difference in the composition of the excipients, using the example of moxonidine, and presents the potential mechanisms underlying them.

Keywords: bioequivalence, safety, excipients, reproduced medicinal products, moxonidine.

For citation: Pereverzev A.P. Original and reproduced medicinal products: are they comparable? Emphasis on moxonidine. RMJ. 2021;9:6–10.