Results 11 to 20 of about 306 (101)

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope for the treatment of adult patients with growth hormone deficiency [PDF]

Therapeutic Advances in Endocrinology and Metabolism, 2012
Objective : To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of adult patients with growth hormone deficiency (GHD).
Paolo Beck-Peccoz, Francesco Minuto, Alfonso Leal-Cerro, Markus Zabransky, Günter Stalla   +4 more
doaj   +2 more sources

Ten years of biosimilars in Europe: development and evolution of the regulatory pathways [PDF]

Drug Design, Development and Therapy, 2017
Martin Schiestl,1 Markus Zabransky,2 Fritz Sörgel3,4 1Sandoz GmbH, Kundl, Austria; 2Sandoz Biopharmaceuticals, Hexal AG, Holzkirchen, Germany; 3Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany; 4Institute of ...
Schiestl M, Zabransky M, Sörgel F
doaj   +3 more sources

Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies [PDF]

BMC Endocrine Disorders, 2020
Background In 2007, Omnitrope® was the first biosimilar recombinant human growth hormone (rhGH) to be approved in Sweden for treatment in adults and children. Over 10 years’ safety and effectiveness data for biosimilar rhGH can now be presented.
Elena Lundberg, Berit Kriström, Hichem Zouater, Anna Deleskog, Charlotte Höybye   +4 more
doaj   +2 more sources

Growth hormone treatment in children with Prader–Willi syndrome: safety and effectiveness data from the PATRO Children study [PDF]

Therapeutic Advances in Endocrinology and Metabolism
Background: Recombinant human growth hormone (rhGH, somatropin) therapy is approved in children with Prader–Willi syndrome (PWS). Objectives: To report safety and effectiveness data for children with PWS treated with biosimilar rhGH (Omnitrope ® , Sandoz)
Constanze Lämmer, Philippe Backeljauw, Maite Tauber, Shankar Kanumakala, Sandro Loche, Karl Otfried Schwab, Roland Pfäffle, Charlotte Höybye, Elena Lundberg, Jovanna Dahlgren, Anna E. Ek, Tadej Battelino, Berit Kriström, Altaher Esmael, Markus Zabransky   +14 more
doaj   +2 more sources

A follow-up study to monitor adult height among Spanish children with growth hormone deficiency who received biosimilar human recombinant growth hormone (Omnitrope®) during a phase III clinical trial. [PDF]

Adv Ther, 2015
An initial Phase III clinical trial has evaluated the efficacy and safety of biosimilar recombinant human growth hormone (rhGH; Omnitrope(®), Sandoz) in Spanish children with growth hormone deficiency (GHD).
Borrás Pérez V, López-Siguero JP, Martínez G, Corripio R, Fernández JM, Labarta JI, Ferrer M, Cabrinety N, Prieto P, Ramón-Krauel M, Bosch J, Espino R, Palla Garcia M, Rebollo FJ.   +13 more
europepmc   +4 more sources

Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data. [PDF]

Drug Des Devel Ther, 2017
In 2006, the European Medicines Agency (EMA) approved Omnitrope(®) as a biosimilar recombinant human growth hormone (rhGH), on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®), Pfizer).
López-Siguero JP, Pfäffle R, Chanson P, Szalecki M, Höbel N, Zabransky M.   +5 more
europepmc   +3 more sources

Acceptance of a reusable self-injection device for recombinant human growth hormone: final data from a questionnaire-based, cross-sectional, international, multicenter, observational study in pediatric patients. [PDF]

Med Devices (Auckl), 2016
BACKGROUND: A questionnaire-based survey was conducted to assess attitudes toward a reusable self-injection system (SurePal™) among pediatric patients with growth disturbances who were prescribed treatment with Omnitrope(®) within routine clinical ...
Schnabel D, Partsch CJ, Houang M, Ehtisham S, Johnstone H, Zabransky M, Kiess W.   +6 more
europepmc   +3 more sources

Erratum to: Switching to Omnitrope(®) from Other Recombinant Human Growth Hormone Therapies: A Retrospective Study in an Integrated Healthcare System. [PDF]

Biol Ther, 2014
Rashid N, Saenger P, Wu YL, Woehling H, Frankel M, Lifshitz F, Muenzberg M, Rapaport R.   +7 more
europepmc   +2 more sources

Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals. [PDF]

Front Med (Lausanne)
Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine.
Klein K, Heisterberg J, Stolk P.
europepmc   +3 more sources

Clinical and Economic Value of a Biosimilar Portfolio to Stakeholders: An Integrative Literature Review. [PDF]

Clinicoecon Outcomes Res
Grace E Fox,1 Mark Bernauer,1 Jennifer M Stephens,1 Bianca Jackson,1 Joshua A Roth,2 Ahmed Shelbaya2,3 1Strategic Market Access, OPEN Health, Bethesda, MD, USA; 2Global Access and Value, Pfizer Inc., New York, NY, USA; 3Department of Epidemiology ...
Fox GE, Bernauer M, Stephens JM, Jackson B, Roth JA, Shelbaya A.   +5 more
europepmc   +3 more sources