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      Current Status of Biosimilar Growth Hormone

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      Author(s): *
      Publication date (Electronic):
      Journal: International Journal of Pediatric Endocrinology
      Publisher: Hindawi Publishing Corporation

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          Abstract

          As the first wave of biopharmaceuticals is set to expire, biosimilars or follow-on protein products (FOPPs) have emerged. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Recent approval of biosimilar Somatropin (growth hormone) in Europe and the US prompted this paper. The scientific viability of biosimilar growth hormone is reviewed. Efficacy and safety data (growth rates, IGF-1 generation) for up to 7 years for pediatric indications measure up favorably to previously approved growth hormones as reference comparators. While the approval in the US is currently only for treatment of growth hormone deficiency (GHD) in children and adults, the commercial use of approved biosimilar growth hormones will allow in the future for in-depth estimation of their efficacy and safety in non-GH deficient states as well.

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          Efficacy and safety of a new ready-to-use recombinant human growth hormone solution.

          T Romer, Trevor F. Peter, P Saenger … (2016)
          We report 24-month interim results of two multicenter phase III studies in previously untreated children with growth failure secondary to GH deficiency (GHD) that were paramount to the development of a new recombinant human GH (rh- GH, somatropin), approved as the first 'biosimilar' in Europe. Study 1 consisted of 3 parts performed in 89 children. The objective was to compare efficacy and safety of the lyophilized formulation of the new somatropin [Somatropin Powder (Sandoz)] with a licensed reference rhGH preparation and the liquid formulation of the new somatropin [Somatropin Solution (Sandoz)] and to assess long-term efficacy and safety of this ready-to-use Somatropin Solution. Study 2 was performed in 51 children and designed to demonstrate efficacy and safety of Somatropin Powder and to confirm its low immunogenic potential; rhGH was given sc at a daily dose of 0.03 mg/kg. Primary [body height, height SD score (HSDS), height velocity, and height velocity (HV) SD score (HVSDS)] and secondary [IGF-I and IGF binding protein 3 (IGFBP-3)] efficacy endpoints and safety parameters were assessed regularly. In study 1, all treatments showed comparable increases in growth. The baseline-adjusted difference between Somatropin Powder and the reference rhGH product in mean HV was -0.20 cm/yr (95% confidence interval (CI) [-1.34;0.94]) and in mean HVSDS was 0.76 (95% CI [-0.57;2.10]) after 9 months. These very small differences demonstrate comparable therapeutic efficacy between the two treatments. The results of study 2 were consistent with those seen in study 1. Equivalent therapeutic efficacy and clinical comparability in terms of safety and immunogenicity between Somatropin Powder and the reference rhGH product and between Somatropin Powder and Somatropin Solution was demonstrated. The safety and immunogenicity profiles were similar and as expected from experience with rhGH preparations.
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            Similar Biological Medicinal Products Containing Recombinant Human Growth Hormone: European Regulation

            Mira Pavlovic, Elizabeth Girardin, Liliana Kapetanovic … (2007)
            The concept of similar biological medicinal products (‘biosimilar’ medicinal products) allows pharmaceutical companies to develop products based on an abridged dossier once the marketing protection of the ‘reference’ biological medicinal product has expired. A biosimilar medicinal product can be granted a marketing authorization provided that its similarity to a reference product is established in terms of quality, safety and efficacy (step-wise comparability exercise). A decision to launch a biosimilar medicinal product on the market is taken if it has a similar efficacy and comparable or better (less) immunogenicity than the chosen reference biological medicinal product. However, this decision is based on limited data and the comparability program may detect substantial differences in immunogenicity profiles but is likely incapable of detecting rare events. This is why clinical experience, through clinical trials and extensive pharmacovigilance programs, remains the most reliable way to assess the immunogenicity and tolerance profile of recombinant therapeutic proteins. Substitution of one biological medicinal product by a biosimilar medicinal product is not currently recommended before long-term clinical efficacy and safety have been acquired in all relevant populations. Here we review recent regulatory guidelines provided by EMEA and comment on the marketing authorizations and risk management plans of two recently approved biosimilar somatropins.
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              Growth hormone treatment and neoplasia-coincidence or consequence?

              Ursula S R Röse, Ray Hintz, P Saenger … (2002)
              Article 0 comments Cited 7 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Int J Pediatr Endocrinol
                Journal ID (publisher-id): IJPE
                Title: International Journal of Pediatric Endocrinology
                Publisher: Hindawi Publishing Corporation
                ISSN (Print): 1687-9848
                ISSN (Electronic): 1687-9856
                Publication date (Print): 2009
                Publication date (Electronic): 29 September 2009
                Volume: 2009
                Electronic Location Identifier: 370329
                Affiliations
                Albert Einstein College of Medicine, Bronx, NY 10467, USA
                Author notes

                Recommended by Ron Rosenfeld

                Article
                DOI: 10.1155/2009/370329
                PMC ID: 2777019
                PubMed ID: 19956705
                SO-VID: 06d899d0-f697-402b-8e36-e7766a285fa5
                Copyright © Copyright © 2009 Paul Saenger.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 7 July 2009
                Date accepted : 16 July 2009
                Categories
                Subject: Review Article

                ScienceOpen disciplines: Pediatrics
                Data availability:
                ScienceOpen disciplines: Pediatrics

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