Omnitrope (somatotropin) / Sandoz - LARVOL DELTA

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University | Initiation date: Jun 2025 ➔ Jan 2026

Trial initiation date • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

PATIENT DYNAMICS AND REAL-WORLD INSIGHTS FROM A SOMATROPIN PATIENT SUPPORT PROGRAM (PSP): OUTCOMES FROM 24,000 TREATED PATIENTS IN BRAZIL. (ESPE-ESE 2025) - "Since 2011, a PSP was implemented in Brazil to support all pediatric patients treated with Omnitrope® (somatropin), offering nurse assistance, needle supply, instructional visits, thermal packaging, sharps collectors, WhatsApp messages, and educational materials... We analyzed the dynamics of a large somatropin PSP over 13 years. Patient enrollment was boosted by shortages of other somatropin products. The services provided by the PSP were highly appreciated by the patients and likely played a role in the observed high persistence in the program."

Clinical • Real-world • Real-world evidence • Endocrine Disorders • Infectious Disease • Novel Coronavirus Disease • Pediatrics

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University | Trial completion date: Feb 2027 ➔ Feb 2028 | Initiation date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial initiation date • Trial primary completion date • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Safety and Effectiveness of a Biosimilar Recombinant Growth Hormone in Adults with Growth Hormone Deficiency: Analysis of Final Data from PATRO Adults, an International Post-Marketing Surveillance Study. (PubMed, Drug Des Devel Ther) - "Body mass index remained stable while blood lipid levels improved from baseline to 5 years. Final data from PATRO Adults confirm that biosimilar rhGH (Omnitrope) is not associated with any unexpected safety signals, with no evidence of increased diabetogenic or carcinogenic risk, and is effective in real-world clinical practice."

Journal • P4 data • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Metabolic Disorders • Musculoskeletal Pain • Oncology • GH1 • IGF1

Long-term safety and effectiveness of a somatropin biosimilar (Omnitrope®) in children requiring growth hormone therapy: analysis of final data of Italian patients enrolled in the PATRO children study. (PubMed, Endocrine) - "This final analysis extends the interim analysis findings from the PATRO Children study and confirms the long-term safety and effectiveness of Omnitrope® in Italian pediatric patients with growth disturbances."

Journal • Review • Pain • Pediatrics • IGF1

Growth hormone treatment in children with Prader-Willi syndrome: safety and effectiveness data from the PATRO Children study. (PubMed, Ther Adv Endocrinol Metab) - "To report safety and effectiveness data for children with PWS treated with biosimilar rhGH (Omnitrope®, Sandoz) in the PAtients TReated with Omnitrope (PATRO) Children study...These data suggest that biosimilar rhGH is well tolerated and effective in patients with PWS managed in real-life clinical practice. Patients with PWS should continue to be closely monitored for well-known safety issues (including respiratory, sleep, and glucose metabolism disorders, and scoliosis) during rhGH treatment."

Journal • Diabetes • Metabolic Disorders • Obstructive Sleep Apnea • Prader–Willi syndrome • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University | Initiation date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial initiation date • Trial primary completion date • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University

New P1 trial • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Dexamethasone/Pancreatic Clamp P&F (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Columbia University | N=16 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Dexamethasone/Pancreatic Clamp P&F (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Columbia University | Initiation date: Dec 2023 ➔ Jul 2024

Trial initiation date • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Safety and Effectiveness of a Biosimilar Recombinant Human Growth Hormone in Children Requiring Growth Hormone Treatment: Analysis of Final Data from PATRO Children, an International, Post-Marketing Surveillance Study. (PubMed, Drug Des Devel Ther) - "Omnitrope® (somatropin) was approved as a biosimilar recombinant human growth hormone (rhGH) in 2006...This final analysis of the PATRO Children study indicates that biosimilar rhGH is well tolerated and effective in real-world clinical practice. These data are consistent with the well-characterized safety profile of rhGH treatment in pediatric patients."

Journal • P4 data • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Metabolic Disorders • Oncology • Pain • Pediatrics • Small for Gestational Age • Type 2 Diabetes Mellitus

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch. (PubMed, Drug Saf) - "This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity."

Biosimilar launch • Journal • Real-world • Real-world evidence

Dexamethasone/Pancreatic Clamp P&F (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Columbia University

New P1 trial • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Obesity

Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: Northwell Health

New P3 trial • Endocrine Disorders • Growth Hormone Deficiency • IGF1 • IGFBP3

Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA) (clinicaltrials.gov) - P4 | N=278 | Completed | Sponsor: Sandoz | Active, not recruiting ➔ Completed

Trial completion • Small for Gestational Age • IGF1 • IGFBP3

Safety and effectiveness of Omnitrope (somatropin) in PATRO Children: a multi-center, post-marketing surveillance study comparison of US and international cohort data. (PubMed, Eur J Pediatr) - "Omnitrope® treatment appears to be well tolerated and effective in US patients and those from other countries. Across the pediatric indications included, there was no evidence of an increased risk of developing uncommon or unexpected AEs with rhGH."

Journal • P4 data • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Metabolic Disorders • Oncology • Pediatrics

Lonapegsomatropin (Skytrofa) for growth hormone deficiency. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Endocrine Disorders • Growth Hormone Deficiency

[VIRTUAL] The efficacy and safety of recombinant biosimilar growth hormone treatment in children with GHD and SGA: a Czech retrospective national longitudinal study (ESPE 2021) - "The aim of our study is to assess height gain and safety of therapy with biosimilar rhGH (Omnitrope®, Sandoz) in Czech children with GHD and SGA over the first three years of treatment and to compare our data with longitudinal international study GeNeSIS Italian Cohort (Humatrope®, Eli Lilly). Our data confirm significant improvement of growth parameters and safety of therapy with biosimilar rhGH Omnitrope® in Czech children with GHD and SGA which is consistent with results from international database GeNeSIS study."

Observational data • Retrospective data • Endocrine Disorders • Growth Hormone Deficiency • Infectious Disease • Nephrology • Respiratory Diseases • Small for Gestational Age

Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA) (clinicaltrials.gov) - P4; N=278; Active, not recruiting; Sponsor: Sandoz; Trial completion date: Jun 2021 ➔ Jan 2022; Trial primary completion date: Jun 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Small for Gestational Age • IGF1 • IGFBP3

Safety and Effectiveness of Recombinant Human Growth Hormone in Children with Turner Syndrome: Data from the PATRO Children Study. (PubMed, Horm Res Paediatr) - "These data suggest that biosimilar rhGH is well tolerated and effective in TS patients managed in real-life clinical practice. Optimization of rhGH dose may contribute to a higher AH."

Clinical • Journal • CNS Disorders • Genetic Disorders • Hypertension • Immunology • Pediatrics • Turners Syndrome

Long-term follow up of carbohydrate metabolism and adverse events after termination of Omnitrope® treatment in children born small for gestational age. (PubMed, Ther Adv Endocrinol Metab) - "None of the participating subjects, who had all been previously treated with Omnitrope® in a phase IV study, developed diabetes during this follow-up study. In addition, no other unexpected or concerning safety signals were observed."

Adverse events • Clinical • Journal • Diabetes • Gynecology • Hematological Disorders • Infectious Disease • Metabolic Disorders • Pediatrics • Septic Shock • Small for Gestational Age

Sandoz Canada congratulates the Quebec government on implementing a shift towards biosimilars (GlobeNewswire) - "The shift announced by Quebec will follow a similar approach to policies introduced in British Columbia, Alberta and recently in New Brunswick to transition patients who use a reference biologic to a biosimilar. This will contribute to substantial annual savings that can be reinvested in healthcare and innovative new drugs. The transition will take place under the supervision of the attending physicians and patients will continue receiving safe and effective treatment. Sandoz Canada has a portfolio of six biosimilars (Omnitrope, Rixymio, Erelzi, Hyrimoz, Ziextenzo and Inclunox)."

Commercial • Immunology • Oncology

Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009-2019. (PubMed, Pharmaceuticals (Basel)) - "Since the first biosimilar medicine, Omnitrope (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain...We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions."

HEOR • Journal

Safety and effectiveness of replacement with biosimilar growth hormone in adults with growth hormone deficiency: results from an international, post-marketing surveillance study (PATRO Adults). (PubMed, Pituitary) - "Data from PATRO Adults indicate biosimilar rhGH (Omnitrope) is not associated with any unexpected safety signals, and is effective in adults with GHD treated in real-world clinical practice."

Clinical • Journal • P4 data • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Musculoskeletal Pain • Pain • IGF1

PATRO children, a multi-center, non-interventional study of the safety and effectiveness of Omnitrope (somatropin) treatment in children: update on the United States cohort. (PubMed, J Pediatr Endocrinol Metab) - "Omnitrope appears to be well tolerated and effective in the majority of patients, without evidence of an increased risk of developing unexpected AEs, diabetes mellitus, or new malignancies during treatment."

Clinical • Journal • Observational data • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Idiopathic Short Stature • Metabolic Disorders • Oncology • Pediatrics