title: Biosimilar growth hormone.
abstract: As the first wave of biopharmaceuticals is expiring, biosimilars or follow-on -protein products (FOPP's) have emerged. Biosimilar drugs are cheaper than the originator/comparator drug. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Biosimilar soamtropin has been approved in both the US and Europe. The scientific viability of biosimilar drugs and especially growth hormone has been proven by several rigorously conducted clinical trials. Efficacy and safety data (growth rates, IGF-1 generation) for up to 7 y for pediatric indications measure up favorably to previously approved growth hormones which served as reference comparators. The Obama Administration appears to be committed to establish innovative pathways for the approval of biologics and biosimilars in the US. The cost savings in health care expenditures will be substantial as the global sales of biologics have reached $ 93 billion in 2009.
authors: Department of Pediatrics, Division of Pediatric Endocrinology, Albert Einstein College of Medicine, Bronx, NY, USA. phsaenger@aol.com
authors: Paul
authors: P
authors: Saenger
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology* / Q000627:therapeutic use; D002648:Child; D017277:Drug Approval; D016568:Drugs, Generic / Q000494:pharmacology* / Q000627:therapeutic use; D005060:Europe; D019382:Human Growth Hormone / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D009965:Orphan Drug Production; D014481:United States
chemical_list: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic; D019382:Human Growth Hormone