Sandoz Egypt introduces OMNITROPE 15mg biosimilar growth hormone for the treatment of short stature

Sandoz the global leader in generic and biosimilar medicines, today announced the introduction of its 15mg/1.5ml concentration of the OMNITROPE biosimilar growth hormone for the treatment of short stature to the Egyptian market, as part of its ongoing efforts to support Egypt’s Vision 2030. Local healthcare authorities remain committed to addressing various health challenges to enhance public health for current and future generations, and help build a healthier, more productive workforce.

Research conducted at the Suez Canal University endocrinology outpatient clinic in Ismailia City, Egypt and released in 2024, underscored the importance of short stature treatment, with findings indicating that treatment with growth hormone significantly improved physical, social, psychological, and environmental quality of life.

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“In children and adolescents, growth hormone is used to treat growth disturbance due to insufficient secretion of growth hormone, associated with Turner syndrome, with chronic renal insufficiency, in short children/adolescents born small for gestational age, or associated with Prader-Willi syndrome (PWS). The biosynthetic/synthetic hormone is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH),” Dr. Mona Salem, Professor of Paediatric Endocrinology at Ain Shams University and President of the Egyptian Society of Paediatric Endocrinology & Diabetes, said.

“Short stature is diagnosed in children or adolescents who are well below the average height for their age and gender, which may be due to genetic factors or underlying health conditions. Studies show that short stature prevalence varies geographically, with a genetic predisposition, as well as nutritional and environmental factors, playing an important role,” Dr Salem added.
A cross-sectional study conducted between January 2018 and January 2020 involving 33,150 Egyptian children aged 6 to 11 showed that 17% of the sample had short stature, with 40.8% attributed to familial factors and 24.2% to constitutional causes.
“As noted, short stature affects children and adolescents, not only physically but also psychologically. Growth hormone is one of the most effective treatments for the aforementioned growth disturbances. The dosage is carefully calculated based on weight, underlying cause, puberty stage, as well as stimulated growth hormone test results, to achieve the best possible final height outcomes,” Dr. Rasha Tarif, Head of the Paediatric Endocrinology Unit at Ain Shams University and Chair of European Society for Paediatric Endocrinology (ESPE) Education and Training Committee, said.
Young patients affected require therapeutic intervention to accelerate growth velocity before growth plates have fused, after which the height cannot be gained. Human growth hormone must therefore be administered during this window of opportunity to ensure a normal final adult height.
“Growth hormone plays a critical role in effective treatment plans, but ensuring its availability has been a challenge in recent years. This challenge is being addressed through ongoing efforts to secure sufficient quantities to ensure uninterrupted treatment until puberty is complete, and in some cases, for life. Treatment continuity, along with proper follow-up with a specialized physician, is essential for achieving optimal results,” Dr. Tarif added.
This new concentration is being made available and at an affordable cost, expanding treatment options in line with the latest global scientific standards. This will allow for a better patient response as well as an effective and safe treatment journey by minimizing interruptions. Securing the reliable availability of this human growth hormone reinforces medical efforts to provide comprehensive care for children and reflects the Egyptian medical community’s commitment to delivering advanced treatment solutions for patients in need.
“The Egyptian government, within the context of the Egypt Vision 2030, has shown strong commitment to reducing the prevalence of short stature among children, aiming to improve public health for current and future generations, and help build a healthier, more productive workforce, in line with the national vision for sustainable development,” Sameh Elbagoury, Sandoz Egypt Country Head, said.
“Our top priority at Sandoz is to develop affordable biosimilars for high-quality biologics and ensure that as many patients as possible have access to them. Introducing the 15mg concentration of our well-established Omnitrope growth hormone allows us to help local authorities meet the increase in demand for growth hormones, reflecting the positive impact and notable success achieved by the Presidential Initiative for the Early Detection of Anaemia, Obesity and Short Stature,” Elbagoury added.
Sandoz Omnitrope was approved by the US Food and Drug Administration and the European Medicines Agency in 2006 and approvals in other countries have since followed. Sandoz has also established a long-term, post-marketing surveillance program for its product to monitor its safety over time.