Similar biological medicinal products currently licensed in the European union - Overview of non-clinical study programs
This article summarizes the non-clinical evaluations performed for these medicinal products and provides a comparison with the current requests for non-clinical evaluation as laid down in the respective EU regulatory guidelines. (Source: Biologicals)
Source: Biologicals - November 3, 2014 Category: Biology Source Type: research
Double‐injection capillary electrophoresis for the identification of analytes
This article is protected by copyright. All rights reserved (Source: Electrophoresis)
Source: Electrophoresis - July 17, 2014 Category: Biochemistry Authors: Ahmad Amini Tags: Research Article Source Type: research
Biosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?
This article reviews the available evidence on the use of biosimilar G-CSF in this setting. Aggregate clinical evidence supports the assessment by the EMA of biosimilar and originator G-CSF as highly biologically similar, with respect to desired and undesired effects.
PMID: 24965197 [PubMed - as supplied by publisher] (Source: Transfusion)
Source: Transfusion - June 26, 2014 Category: Hematology Authors: Bonig H, Becker PS, Schwebig A, Turner M Tags: Transfusion Source Type: research
Generation and characterization of nanobodies against rhGH expressed as sfGFP fusion protein.
Abstract
Growth hormone (GH) deficiencies are diagnosed in most children with short stature and treated with a long course of administrating expensive and daily doses of recombinant human GH (rhGH or Somatropin(®)). This work describes for the first time the production of several GH specific nanobodies with great potential in the field of GH production and detection. Nanobodies are the smallest intact antigen binders derived from heavy chain-only antibodies (HCAbs) of camelids. They are very stable, highly soluble and are produced as recombinant proteins in E. coli at an affordable cost for various biotec...
Source: General and Comparative Endocrinology - May 22, 2014 Category: Endocrinology Authors: Abbady AQ, Al-Shemali R, Assaad JM, Murad H Tags: Gen Comp Endocrinol Source Type: research
Pharmacologic Options for Intestinal Rehabilitation in Patients With Short Bowel Syndrome.
Abstract
A primary goal of intestinal rehabilitation programs is to facilitate intestinal adaptation. Adult patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition and/or intravenous fluid (PN/IV) support have 2 hormonal pharmacologic treatment options available that may promote intestinal growth: a glucagon-like peptide 2 analog (teduglutide) and recombinant human growth hormone (somatropin). In two phase III clinical trials (N = 169), 24 weeks of teduglutide administered to outpatients with SBS resulted in significant decreases in PN/IV volume requirements of 2.5-4.4 L/wk. In a...
Source: JPEN Journal Of Parenteral And Enteral Nutrition - March 10, 2014 Category: Nutrition Authors: Jeppesen PB Tags: JPEN J Parenter Enteral Nutr Source Type: research
Regional tenders on biosimilars in Italy: An empirical analysis of awarded prices
Discussion: Our analysis confirms the theory that worthwhile savings can be generated in tenders, once the bid is designed in such a way that competition can produce its effects, i.e. allowing more than one manufacturer to tender. However, most of the Italian regional tenders on off-patent bioagents do not seem to exploit potential competition to the full. (Source: Health Policy)
Source: Health Policy - March 6, 2014 Category: Health Management Authors: Sandro Curto, Simone Ghislandi, Katelijne van de Vooren, Silvy Duranti, Livio Garattini Tags: Pharmaceutical policies and their effects Source Type: research
Intestinal Adaptation Following Resection.
Abstract
Intestinal adaptation is a natural compensatory process that occurs following extensive intestinal resection, whereby structural and functional changes in the intestine improve nutrient and fluid absorption in the remnant bowel. In animal studies, postresection structural adaptations include bowel lengthening and thickening and increases in villus height and crypt depth. Functional changes include increased nutrient transporter expression, accelerated crypt cell differentiation, and slowed transit time. In adult humans, data regarding adaptive changes are sparse, and the mechanisms underlying inte...
Source: JPEN Journal Of Parenteral And Enteral Nutrition - February 28, 2014 Category: Nutrition Authors: Tappenden KA Tags: JPEN J Parenter Enteral Nutr Source Type: research
One-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age
Conclusion
This interim analysis shows that short children born SGA can be effectively and safely treated with rhGH and that rhGH treatment has no major impact on carbohydrate metabolism after the first year of treatment. (Source: Biologics in Therapy)
Source: Biologics in Therapy - January 28, 2014 Category: Drugs & Pharmacology Source Type: research
Somatropin treatment of spinal muscular atrophy: A placebo-controlled, double-blind crossover pilot study
Abstract: In preclinical studies growth hormone and its primary mediator IGF-1 have shown potential to increase muscle mass and strength. A single patient with spinal muscular atrophy reported benefit after compassionate use of growth hormone. Therefore we evaluated the efficacy and safety of growth hormone treatment for spinal muscular atrophy in a multicenter, randomised, double-blind, placebo-controlled, crossover pilot trial. Patients (n=19) with type II/III spinal muscular atrophy were randomised to receive either somatropin (0.03mg/kg/day) or placebo subcutaneously for 3months, followed by a 2-month wash-out phase be...
Source: Neuromuscular Disorders - December 2, 2013 Category: Neurology Authors: J. Kirschner, D. Schorling, D. Hauschke, C. Rensing-Zimmermann, U. Wein, U. Grieben, G. Schottmann, U. Schara, K. Konrad, W. Müller-Felber, S. Thiele, E. Wilichowski, E. Hobbiebrunken, G.M. Stettner, R. Korinthenberg Tags: Research papers Source Type: research
Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden
ConclusionPatients were successfully switched from originator to biosimilar rhGH (somatropin), with no negative impact on growth, and no serious or unexpected adverse drug reactions. The switch from originator to biosimilar rhGH is associated with substantial cost savings. (Source: Biologics in Therapy)
Source: Biologics in Therapy - June 1, 2013 Category: Drugs & Pharmacology Source Type: research
Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden
Conclusion
Patients were successfully switched from originator to biosimilar rhGH (somatropin), with no negative impact on growth, and no serious or unexpected adverse drug reactions. The switch from originator to biosimilar rhGH is associated with substantial cost savings. (Source: Biologics in Therapy)
Source: Biologics in Therapy - June 1, 2013 Category: Drugs & Pharmacology Source Type: research
Biosimilars in IBD: hope or expectation?
Introduction A biosimilar is a biological medicine that enters the market subsequent to expiration of the patent of an original reference product and its similarity to the reference medicine exhibits ‘no clinically meaningful differences in terms of quality, safety and efficacy’.1 In practice, patents protect a reference product for 10 years after its approval before registration for a similar biological medicine can be applied for.1 The term ‘biosimilar’ is recognised by all regulators, but synonyms include ‘similar biotherapeutic product’ (WHO) and ‘subsequent-entry biologic...
Source: Gut - April 30, 2013 Category: Gastroenterology Authors: Gecse, K. B., Khanna, R., van den Brink, G. R., Ponsioen, C. Y., Lowenberg, M., Jairath, V., Travis, S. P. L., Sandborn, W. J., Feagan, B. G., D'Haens, G. R. A. M. Tags: Crohn's disease Leading article Source Type: research
[Programme review of somatropin deficit in pediatrics at the Hospital Universitario Virgen del Rocío.]
Conclusions: We observed that the treatment instituted appeared highly effective in both groups of patients, allowing a favorable increase in height.
PMID: 23789761 [PubMed - as supplied by publisher] (Source: Farmacia Hospitalaria)
Source: Farmacia Hospitalaria - March 1, 2013 Category: Drugs & Pharmacology Authors: Lavaredas A, de la Puerta R, Alvarez Del Vayo C Tags: Farm Hosp Source Type: research
Somatropin: Slipped capital femoral epiphysis in a child: case report
(Source: Reactions)
Source: Reactions - February 6, 2013 Category: Drugs & Pharmacology Tags: Short communication Source Type: research
Somatropin: Melanoma: 2 case reports
(Source: Reactions)
Source: Reactions - January 9, 2013 Category: Drugs & Pharmacology Tags: Short communication Source Type: research
