| Title |
Ten years of clinical experience with biosimilar human growth hormone: a review of safety data
|
|---|---|
| Published in |
Drug Design, Development and Therapy, May 2017
|
| DOI | 10.2147/dddt.s130909 |
| Pubmed ID | |
| Authors |
Maria Victoria Borrás Pérez, Berit Kriström, Tomasz Romer, Mieczyslaw Walczak, Nadja Höbel, Markus Zabransky |
| Abstract |
Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope(®) (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®)). Additional concerns that may exist in relation to biosimilar rhGH include safety in indications granted on the basis of extrapolation and the impact of changing to biosimilar rhGH from other rhGH treatments. A substantial data set is available to fully understand the safety profile of biosimilar rhGH, which includes data from its clinical development studies and 10 years of post-approval experience. As of June 2016, 106,941,419 patient days (292,790 patient-years) experience has been gathered for biosimilar rhGH. Based on the available data, there have been no unexpected or unique adverse events related to biosimilar rhGH treatment. There is no increased risk of cancer, adverse glucose homeostasis, or immunogenic response with biosimilar rhGH compared with the reference medicine and other rhGH products. The immunogenicity of biosimilar rhGH is also similar to that of the reference and other rhGH products. Physicians should be reassured that rhGH products have a good safety record when used for approved indications and at recommended doses, and that the safety profile of biosimilar rhGH is in keeping with that of other rhGH products. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Netherlands | 1 | 33% |
| United States | 1 | 33% |
| Unknown | 1 | 33% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 67% |
| Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
The data shown below were compiled from readership statistics for 22 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 22 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 6 | 27% |
| Student > Master | 4 | 18% |
| Other | 2 | 9% |
| Professor | 2 | 9% |
| Librarian | 1 | 5% |
| Other | 2 | 9% |
| Unknown | 5 | 23% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 6 | 27% |
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 18% |
| Biochemistry, Genetics and Molecular Biology | 3 | 14% |
| Computer Science | 1 | 5% |
| Nursing and Health Professions | 1 | 5% |
| Other | 2 | 9% |
| Unknown | 5 | 23% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 26 October 2023.
All research outputs
#14,731,975
of 25,584,565 outputs
Outputs from Drug Design, Development and Therapy
#780
of 2,254 outputs
Outputs of similar age
#160,411
of 325,074 outputs
Outputs of similar age from Drug Design, Development and Therapy
#20
of 49 outputs
Altmetric has tracked 25,584,565 research outputs across all sources so far. This one is in the 41st percentile – i.e., 41% of other outputs scored the same or lower than it.
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We're also able to compare this research output to 49 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 59% of its contemporaries.