scholarly journals The Role of Recombinant Human Growth Hormone Biosimilars in the Management of Growth Disorders

2009 ◽  
Vol 05 (0) ◽  
pp. 47 ◽  
Author(s):  
Tomasz E Romer ◽  
Keyword(s):  
Growth Hormone ◽  
Human Growth Hormone ◽  
Recombinant Dna ◽  
Recombinant Human Growth Hormone ◽  
Human Growth ◽  
Host Cells ◽  
European Medicines Agency ◽  
Marketing Approval ◽  
Growth Disorders ◽  
New Generation

Since ancient times plant and animal tissues have been used as medicines. In the 20th century growth hormone as a purified extraction from human pituitaries was still used to treat growth disorders. Since the genetic engineering of host cells became possible, a new generation of medicines obtained using recombinant DNA (rDNA) technology has emerged. These medicines have been named ‘biopharmaceuticals’. The first biopharmaceutical growth hormones were patented in the 1980s, so already over two decades of clinical experience support the development of a new, off-patent growth hormone preparation obtained by rDNA technology. The European Medicines Agency (EMEA) has put in place a centralised procedure for the approval of new biopharmaceuticals. This procedure includes testing comparability with a reference product and demands post-approval pharmacovigilance. Omnitrope® was the first off-patent recombinant human growth hormone (rhGH) approved on the basis of the biosimilar pathway; it underwent a very demanding approval procedure in 2006 and is now used for several indications in Europe, the US, Canada, Japan, Australia and other countries where it has received marketing approval.

Systemic Reaction to Human Growth Hormone Treated With Acute Desensitization

PEDIATRICS ◽  
1992 ◽  
Vol 90 (1) ◽  
pp. 108-109
Author(s):  
SUSANNAH B. WALKER ◽  
MICHAEL E. WEISS ◽  
DIANA S. TATTONI
Keyword(s):  
Growth Hormone ◽  
Human Growth Hormone ◽  
Recombinant Dna ◽  
Recombinant Human Growth Hormone ◽  
Systemic Reaction ◽  
Human Growth ◽  
Allergic Reactions ◽  
Recombinant Dna Technology ◽  
Recombinant Growth Hormone ◽  
Dna Technology

Recombinant DNA technology has led to increased production and widespread use of recombinant growth hormone. Systemic allergic reactions to recombinant growth hormone such as urticaria, angioedema, or anaphylaxis have not been described in the literature. We report a patient who developed generalized urticaria from recombinant human growth hormone (Humatrope, Eli Lilly and Company) in whom we successfully desensitized to growth hormone using a protocol modified from an insulin desensitization schedule.1 CASE REPORT A 12-year-old girl with hypopituitarism and short stature had been treated with 2 mg to 5 mg of Humatrope (depending on her weight and responsiveness to treatment) intramuscularly 6 days a week for 3 years without any problems.

The effect of treatment with recombinant human growth hormone (rhGH) on linear growth and adult height in children with idiopathic short stature (ISS): a systematic review and meta-analysis

2020 ◽  
Vol 33 (12) ◽  
pp. 1577-1588
Author(s):  
George Paltoglou ◽  
Ioannis Dimitropoulos ◽  
Georgia Kourlaba ◽  
Evangelia Charmandari
Keyword(s):  
Systematic Review ◽  
Growth Hormone ◽  
Short Stature ◽  
Human Growth Hormone ◽  
Adult Height ◽  
Linear Growth ◽  
Meta Analysis ◽  
Recombinant Human Growth Hormone ◽  
Human Growth ◽  
Idiopathic Short Stature

AbstractObjectivesIdiopathic short stature (ISS) is a recognized, albeit a controversial indication for treatment with recombinant human growth hormone (rhGH).The objective of the present study was to conduct a systematic review of the literature and meta-analyses of selected studies about the use of rhGH in children with ISS on linear growth and adult height (AH).MethodsA systematic literature search was conducted to identify relevant studies published till February 28, 2017 in the following databases: Medline (PubMed), Scopus and Cochrane Central Registry of Controlled Trials. After exclusion of duplicate studies, 3,609 studies were initially identified. Of those, 3,497 studies were excluded during the process of assessing the title and/or the abstract. The remaining 112 studies were evaluated further by assessing the full text; 21 of them fulfilled all the criteria in order to be included in the current meta-analysis.ResultsChildren who received rhGH had significantly higher height increment at the end of the first year, an effect that persisted in the second year of treatment and achieved significantly higher AH than the control group. The difference between the two groups was equal to 5.3 cm (95% CI: 3.4–7 cm) for male and 4.7 cm (95% CI: 3.1–6.3 cm) for female patients.ConclusionIn children with ISS, treatment with rhGH improves short-term linear growth and increases AH compared with control subjects. However, the final decision should be made on an individual basis, following detailed diagnostic evaluation and careful consideration of both risks and benefits of rhGH administration.

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