Ten years&amp;#39; clinical experience with biosimilar human growth hormone: a review of efficacy data

López-Siguero, Juan Pedro; Pfäffle, Roland; Chanson, Philippe; Szalecki, Mieczysław; Höbel, Nadja; Zabransky, Markus

doi:10.2147/dddt.s130320

Cited by 13 publications

(10 citation statements)

References 11 publications

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“…In their reviews, Lopez-Siguero et al [ 17 ] and Borras-Perez et al [ 18 ] summarised 10 years of experience with the use of biosimilar rhGH and reported that switches between the reference product or another rhGH-containing product and the biosimilar did not affect therapeutic efficacy or safety. They analysed the results of phase III and IV trials, as well as those of an ongoing post-approval study in patients with growth disorders in the course of growth hormone deficiency or small for gestational age.…”

Section: Effect Of Switching On Therapeutic Efficacy and Safety – CLImentioning

confidence: 99%

Biosimilar switching – current state of knowledge

Wiland¹,

Batko²,

Brzosko³

et al. 2018

Reumatologia

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Evidence from over 10 years of clinical experience demonstrates that biosimilar medicines approved in the European Union can be used for all their registered indications as safely as their originators and with no negative impact on therapeutic efficacy. The debate on the use of biosimilars in rheumatology focuses specifically on the safety of switching between biosimilars and reference products. Studies conducted to date, including randomised double-blind and open-label extension trials, have not demonstrated any significant differences in therapeutic efficacy or safety between patients switched from one medicine to another and those who were continued on a single medicine. According to the latest recommendations for the use of biosimilars in rheumatic diseases, developed by an international task force in 2017, there is no clinical evidence that a single switch from an originator to a biosimilar medicine is associated with any significant risk for patient safety or reduction in therapeutic efficacy.

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Section: Effect Of Switching On Therapeutic Efficacy and Safety – CLImentioning

confidence: 99%

Biosimilar switching – current state of knowledge

Wiland¹,

Batko²,

Brzosko³

et al. 2018

Reumatologia

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“…Hence, post-marketing trials of biosimilar GH are necessary. [ 16 ] In Indian markets, at least two biosimilar GH preparations are available namely Eutropin and Headon. In this study, the innovator GH used was 'Norditropin' which was a Somatropin (rDNA origin) injection, while, the biosimilar GH used was the injection 'Headon' which is synthesized from a strain of Escherichia coli (Recombinant DNA technology).…”

Section: Discussionmentioning

confidence: 99%

“…[ 19 ] Very recent data from various long-term studies worldwide also suggest that the use of biosimilar GH in comparison to the innovator GH is efficient and safe in GHD children. [ 16 ] However, such data in other growth disorders are lacking.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of biosimilar growth hormone in Indian children

Khadilkar

Ekbote

Khadilkar

et al. 2018

Indian J Endocr Metab

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Objective:To study efficacy and safety of use of biosimilar growth hormone (GH) in Indian children with growth disorders.Materials and Methods:We studied 322 children (May 2012–2017) with growth disorders including growth hormone deficiency (GHD), multiple pituitary hormone deficiency (MPHD, idiopathic short stature (ISS), small for gestational age (SGA), and Turner syndrome (TS). Children were treated either with innovator molecule (Norditropin) or biosimilar GH (Headon) with standard dosage protocol for 1 year. Height and weight was measured using standard protocol. Height and BMI for age Z-scores (HAZ, BMIZ), height velocity (HV), and HV Z-score (HVZ) were computed from available data.Results:Mean age of the studied children (n = 322) was 9.6 ± 4.1 years, 32% children had GHD, 39% had ISS, 11% had MPHD, 12% had SGA, and 6% children had TS. There were no serious adverse events; three patients recorded eight instances of headaches, two had rash at injection site, and one each had hives and facial edema. Reactions were mild and were treated symptomatically. At the end of the 1 year of GH therapy, change in HAZ was similar in children from both the innovator and biosimilar GH groups. Similarly, the HV and HVZ were also similar in children from both groups and all the studied growth disorders.Conclusion:Biosimilar GH was effective and safe for treatment in children with growth disorders where GH use is indicated. However, in the view of scarcity of such data a longitudinal study with large sample size is warranted.

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“…Any disorder in the secretion of hGH in childhood or adolescence can lead to a variety of diseases including gigantism, acromegaly, and dwarf diseases [2,3]. hGH has been used in clinics since 1985 to treat a variety of children as well as adults hGH-related disorders, including Prader-Willi syndrome, chronic renal insu ciency, Turner syndrome, AIDS-related wasting, fat accumulation associated with lipodystrophy in adults [4,5]. Furthermore it may also be associated with some metabolic complications and even mellitus diabetes [6].…”

Section: Introductionmentioning

confidence: 99%

Optimization of Expression, Purification and Secretion of Functional Recombinant Human Growth Hormone in Prokaryotic Hosts Using Modified Staphylococcal Protein A Signal Peptide

Rigi

Rostami

Ghomi

et al. 2021

Preprint

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Background: Human Growth Hormone (hGH) is a glycoprotein released from the pituitary gland. Due to the wide range of effects in humans, any disruption in hGH secretion could have serious consequences. This highlights the clinical importance of hGH production in the treatment of different diseases associated with a deficiency of this hormone. The production of recombinant mature hormone in suitable hosts and secretion of this therapeutic protein into the extracellular space can be considered as one of the best cost-effective approaches not only to obtain the active form of the protein but also endotoxin-free preparation. Since the natural growth hormone signal peptide is of eukaryotic origin and is not detectable by any of the E. coli secretory systems, including Sec and Tat, and is therefore unable to secrete hGH in the prokaryotic systems, designing a new and efficient signal peptide is essential to direct hGh to the extracellular space. Results: In this study, using a combination of the bioinformatics design and molecular genetics, the protein A signal peptide from Staphylococcus aureus was modified, redesigned and then fused to the mature hGH coding region. The recombinant hGH was then expressed in E. coli and successfully secreted to the medium through the Sec pathway. Secretion of the hGH into the medium was verified using SDS-PAGE and western blot analysis. Recombinant hGH was then expressed in E. coli and successfully secreted into cell culture medium via the Sec pathway. The secretion of hGH into the extracellular medium was confirmed by SDS-PAGE and Western blot analysis. Furthermore, the addition of glycine was shown to improve hGH secretion onto the culture medium. Equations for determining the optimal conditions were also determined. Functional hGH analysis using an ELISA-based method confirmed that the ratio of the active form of secreted hGH to the inactive form in the periplasm is higher than this ratio in the cytoplasm.Conclusions: Since the native signal protein peptide of S. aureus protein A was not able to deliver hGH to the extracellular space, it was modified using bioinformatics tools and fused to the n-terminal region of hGh to show that the redesigned signal peptide was functional.

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Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data

Cited by 13 publications

References 11 publications

Biosimilar switching – current state of knowledge

Biosimilar switching – current state of knowledge

Efficacy and safety of biosimilar growth hormone in Indian children

Optimization of Expression, Purification and Secretion of Functional Recombinant Human Growth Hormone in Prokaryotic Hosts Using Modified Staphylococcal Protein A Signal Peptide

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