ESPE Abstracts (2014) 82 P-D-3-2-853

Switching From the Original to the Biosimilar Recombinant Human GH - Omnitrope[reg]: an Experience of a Single Paediatric Centre in Spain

Ana Gomez Gilaa & Margarida Palla Garciab


aHospital Universitario Virgen del Rocío, Sevilla, Spain; bSandoz Farmacéutica, Madrid, Spain


Introduction: In 2009/2010 Hospital Virgen del Rocío, Seville, Spain changed the treatment of patients with GH deficiency (GHD) from various original recombinant human GH (rhGH) to a biosimilar rhGh (Omnitrope®, Sandoz).

Objective: To evaluate the consequences on growth parameters of switching treatment, from original rhGHs to Omnitrope® in children with GHD, in a window period of 36 months.

Method: This study was a single centre, retrospective, observational study. It included children with GHD treated with an original rhGH at least 2 years before the switch. Auxological data was obtained from 20 patients.

Results: Data from 15 boys (75%) and five girls (25%) was gathered. The mean age of the patients was 14.5 years. 65% (13) had idiopathic GHD. The mean duration of treatment prior to switching was 38,3 months. At the beginning of treatment the mean height was 105.5±16.2 cm and the height SDS (HSDS) was −3.25±0.93. Eighteen months before the switch the mean height was 118.5±10.9 cm, the HSDS was −2.16±0.80, the HV was 8.77±2.04 cm/year and the HVSDS was 3.87±2.66. At the time of the switch to Omnitrope® the mean height was 128.1±10.6 cm, the HSDS was −1.82±0.88, the HV was 6.20±1.39 cm/year and the HVSDS was 1.03±1.80. Eighteen months after the switch the mean height was 139.4±12.9 cm, the HSDS was −1.41±0.91, the HV was 6.92±2.88 cm/year and the HVSDS was 0.89±1.57. No adverse drug reactions were reported after the switch and three patients had transitory problems with the Omnitrope® device.

Conclusion: The switch from the original to the biosimilar rhGH, Omnitrope®, had no negative impact on the growth of children with GHD. No adverse drug reactions were reported after the switch.

Article tools

My recent searches

No recent searches.