Articolul precedent |
Articolul urmator |
359 11 |
Ultima descărcare din IBN: 2023-12-06 21:01 |
SM ISO690:2012 CAZACU, Radu, RUSNAC, Liliana, VALICA, Vladimir, SCUTARI, Corina, TODIRAŞ, Mihail. Development of biosimilar growth hormon. In: Cercetarea în biomedicină și sănătate: calitate, excelență și performanță, Ed. 1, 20-22 octombrie 2021, Chişinău. Chișinău, Republica Moldova: 2021, p. 434. ISBN 978-9975-82-223-7 (PDF).. |
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Cercetarea în biomedicină și sănătate: calitate, excelență și performanță 2021 | ||||||
Conferința "Cercetarea în biomedicină și sănătate: calitate, excelență și performanță" 1, Chişinău, Moldova, 20-22 octombrie 2021 | ||||||
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Rezumat | ||||||
Background. Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. Objective of the study. Informative presentation on the development of biosimilar growth hormone in Europe and in the Republic of Moldova. Material and Methods. The selection and analysis of 16 bibliographic sources from the PubMed database and from the specialized journals regarding the aspects of biosimilar growth hormone use in medical practice was performed. Results. Human growth hormone was approved by the EMA in 2006 as the world's first biosimilar medicine. Clinical trials show that the product is an effective treatment option for children who require rhGH treatment, and has a safety profile that is consistent with the rhGH class. Therapy with recombinant growth hormone is currently approved for the growth hormone deficiency, Turner syndrome, chronic renal failure, and Prader-Willi syndrome. In 2020, one of the local manufacturers showed interest in developing the branch of biosimilar production, including the biosimilar Growth Hormone that will be obtained based on Pichia pastoris cultures with the insertion of the human gene. Conclusion. The 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. |
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Cuvinte-cheie biosimilar, growth hormone, manufacturers, biosimilar, hormon de creștere, producător |
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