Development of biosimilaries and biosimilar growth hormone

In this article, an informative presentation was made about the development of biosimilar and biosimilar growth hormone in Europe and the Republic of Moldova following the selection and analysis of 37 bibliographic sources from the PubMed database and from specialized journals. Human growth hormone was approved by the EMA in 2006 as the world’s first biosimilar drug. Recombinant growth hormone therapy is currently approved for growth hormone deficiency, Turner syndrome, chronic kidney failure, in children/adolescents born young for gestational age and Prader-Willi syndrome. At the same time, biosimulation therapy is very expensive. In the Republic of Moldova but also in Eastern Europe, the accessibility of biological medicines is extremely low due to the lack of local or regional producers. Th e development of the biosimilar production branch, including the biosimilar growth hormone in the Republic of Moldova, will be an attractive and pharmacoeconomically advantageous option for the therapeutic arsenal.