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.

Case Report: Human Recombinant Growth Hormone Therapy in a DSH Cat Presented With Dwarfism

A 6-month-old kitten, male, domestic shorthair cat was presented with dwarfism, ocular and nasal discharge, and Ascaris infestation. Congenital hyposomatotropism was diagnosed on the basis of serum level of insulin-like growth factor-1 (IGF-I). The cat was treated with human recombinant growth hormone for 9 weeks. After that, his liver enzymes became elevated, and the therapy was discontinued. His IGF-I levels were normal at the end of the therapy. Normal IGF-I was present 3 months after discontinuation of therapy with human recombinant growth hormone and even half a year after the discontinuation. All other comorbidities were addressed with the therapy. The cat is now the size of normal cats, living with the first author.

Karyotype Abnormalities in the X Chromosome Predict Response to the Growth Hormone Therapy in Turner Syndrome

Short stature is characteristic for Turner syndrome (TS) patients, and particular karyotype abnormalities of the X chromosome may be associated with different responsiveness to recombinant human GH (rhGH) therapy. The aim of the study was to analyze the effect of different types of TS karyotype abnormalities on the response to rhGH therapy. A total of 57 prepubertal patients with TS treated with rhGH with a 3 year follow-up were enrolled in the study and categorized according to their karyotype as X monosomy (n = 35), isochromosome (n = 11), marker chromosome (n = 5), or X-mosaicism (n = 6). Height and height velocity (HV) were evaluated annually. In the first year, all groups responded well to the therapy. In the second year, HV deteriorated significantly in X-monosomy and isochromosome in comparison to the remaining two groups (p = 0.0007). After 3 years of therapy, all patients improved the score in comparison to their target height, but better outcomes were achieved in patients with marker chromosome and X-mosaicism (p = 0.0072). X-monosomy or isochromosome determined a poorer response during the second and third year of rhGH therapy. The results of the study indicate that the effects of rhGH therapy in patients with TS may depend on the type of TS karyotype causing the syndrome.