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https://www.readbyqxmd.com/read/29144113/-can-we-transfer-the-mechanisms-of-the-generics-market-to-biosimilars
#1
Ch O Jacke, F Wild
Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period...
December 15, 2016: Versicherungsmedizin
https://www.readbyqxmd.com/read/29109363/efficacy-and-safety-of-two-doses-of-norditropin%C3%A2-somatropin-in-short-stature-due-to-noonan-syndrome-a-2-year-randomized-double-blind-multicenter-trial-in-japanese-patients
#2
Keiichi Ozono, Tsutomu Ogata, Reiko Horikawa, Yoichi Matsubara, Yoshihisa Ogawa, Keiji Nishijima, Susumu Yokoya
This randomized double-blind multicenter trial (NCT01927861) evaluated the growth-promoting effect and safety of Norditropin(®) (NN220; somatropin) in Japanese children with short stature due to Noonan syndrome. Prepubertal children aged 3-<11 years (boys) or 3-<10 years (girls) with Noonan syndrome were randomized to receive GH 0.033 mg/kg/day (n = 25, mean age 6.57 years, 11 females) or 0.066 mg/kg/day (n = 26, mean age 6.06 years, eight females) for 104 weeks. Change in height standard deviation score (HSDS) from baseline was analyzed based on an ANCOVA model...
November 7, 2017: Endocrine Journal
https://www.readbyqxmd.com/read/29051812/patients-perceptions-on-the-usability-of-the-surepal%C3%A2-self-injection-device-for-omnitrope-%C3%A2-a-questionnaire-based-observational-study-conducted-in-paediatric-patients-in-france
#3
Régis Coutant, Clémentine Dupuis, Patricia Pigeon, Phillipe Rebaud
BACKGROUND: A questionnaire-based survey was conducted to evaluate attitudes towards a reusable self-injection system, SurePal™, among paediatric patients with growth disturbances who were prescribed treatment with somatropin (Omnitrope(®)) as part of routine clinical practice. METHODS: This cross-sectional survey was incorporated into the multinational, multi-centre, noninterventional PAtients TReated with Omnitrope(®) (PATRO) Children study. Questions were mainly focused on five areas: the attractiveness of SurePal™; training received; use of the device; opinion of the low-drug wastage system; experience compared with previous devices used (among pretreated patients)...
September 2017: Therapeutic Advances in Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28975078/adding-intra-articular-growth-hormone-to-platelet-rich-plasma-under-ultrasound-guidance-in-knee-osteoarthritis-a-comparative-double-blind-clinical-trial
#4
Poupak Rahimzadeh, Farnad Imani, Seyed-Hamid-Reza Faiz, Mahmoud-Reza Alebouyeh, Damoon Azad-Ehyaei, Leila Bahari, Arash Memarian, Kyung-Hoon Kim
INTRODUCTION: Intra-articular injections of platelet rich plasma (PRP) for the treatment of knee osteoarthritis have been shown to reduce pain and improve joint function. The aim of this study is to examine the joint function by adding intra-articular growth hormone to platelet rich plasma. This study was performed on the individuals with knee osteoarthritis and under ultrasound guidance. METHODS: Fifty four patients who were scheduled for ultra-sound guided intra-articular injection were enrolled in the study...
December 2016: Anesthesiology and Pain Medicine
https://www.readbyqxmd.com/read/28926879/-systematic-evaluation-on-effectiveness-and-safety-of-recombinant-human-growth-hormone-in-treating-adult-patients-with-severe-burn
#5
F Y Tian, B Wu, T Xu, X H Jiang
Objective: To systcmatically evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in treating adults with severe burn. Methods: Databases including PubMed, Cochrane Library, and Embase were searched using key words " burns, thermal, human growth hormone, growth hormone, hGH, and somatropin (human)" , and China Biology Medicine disc, Chinese Journals Full-text Database, VIP Database, and Wanfang Database were searched using key words in Chinese version "," to obtain the randomized controlled trials about rhGH in the treatment of adults with severe burn from the establishment of each database to December 2016...
September 20, 2017: Zhonghua Shao Shang za Zhi, Zhonghua Shaoshang Zazhi, Chinese Journal of Burns
https://www.readbyqxmd.com/read/28923784/assessment-of-quality-of-life-on-4-year-growth-hormone-therapy-in-japanese-patients-with-adult-growth-hormone-deficiency-a-post-marketing-multicenter-observational-study
#6
Hitoshi Ishii, Akira Shimatsu, Hiromi Nishinaga, Osamu Murai, Kazuo Chihara
OBJECTIVE: Improvement of quality of life (QOL) by growth hormone (GH) therapy was not demonstrated in Japanese adult growth hormone deficiency (AGHD) patients by either the QOL Assessment of Growth Hormone Deficiency in Adults or the Questions on Life Satisfaction-Hypopituitarism, which are widely used to evaluate QOL in Western AGHD patients. We therefore evaluated QOL in Japanese AGHD patients receiving recombinant GH, Norditropin® (Novo Nordisk A/S, Denmark), using the newly developed Adult Hypopituitarism Questionnaire (AHQ)...
September 1, 2017: Growth Hormone & IGF Research
https://www.readbyqxmd.com/read/28871421/biosimilar-uptake-by-british-local-formularies-a-cross-sectional-study
#7
Saja Alnahar, Rachel A Elliott, Murray D Smith
Background Biological medicines are starting to lose their patent protection, so similar, inexact copies (biosimilars) are being developed and licensed. The high acquisition costs of biologics for healthcare providers could be reduced by switching to biosimilars, thus alleviating budgetary pressures and increasing patient access. Therefore, the acceptance of biosimilars by prescribers in Great Britain (GB; England, Scotland, Wales) needs to be described and understood. Objective To determine uptake of the first wave of biosimilars (somatropin, epoetin, filgrastim) by local formularies (lists of preferred medicines for prescribing in local healthcare settings)...
September 4, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28780521/early-growth-hormone-treatment-start-in-childhood-growth-hormone-deficiency-improves-near-adult-height-analysis-from-nordinet%C3%A2-international-outcome-study
#8
MULTICENTER STUDY
Michel Polak, Jo Blair, Primoz Kotnik, Effie Pournara, Birgitte Tønnes Pedersen, Tilman R Rohrer
OBJECTIVE: To investigate the effect of age at growth hormone (GH) treatment start on near adult height (NAH) in children with isolated GH deficiency (GHD). DESIGN: NordiNet® International Outcome Study (IOS) (Nbib960128), a non-interventional, multicentre study, evaluates the long-term effectiveness and safety of Norditropin® (somatropin) (Novo Nordisk A/S) in the real-life clinical setting. METHODS: Patients (n = 172) treated to NAH (height at ≥18 years, or height velocity <2 cm/year at ≥16 (boys) or ≥15 (girls) years) were grouped by age (years) at treatment start (early (girls, <8; boys, <9), intermediate (girls, 8-10; boys, 9-11) or late (girls, >10; boys, >11)) and GHD severity (<3 ng/mL or 3 to ≤10 ng/mL)...
November 2017: European Journal of Endocrinology
https://www.readbyqxmd.com/read/28720174/selective-determination-of-human-growth-hormone-somatropin-in-the-presence-of-its-chemical-degradation-products
#9
Mamdouh R Rezk, Marwa F Mohamed, Faten Abdelaziz Fathalla, Mostafa A Shehata
A rapid and sensitive HPLC method was developed and validated for selective determination of the human growth hormone (hGH) somatropin in the presence of its deamidated and oxidized degradation products. Reversed-phase chromatography with an acetonitrile and ammonium bicarbonate mobile phase in gradient elution mode was used. A short run time of 15 min allowed rapid and cost-effective analysis, with an average retention time of 7.4 min for native hGH, 6.2 min for its deamidated form, and 4.3 and 6 min for its oxidized variants...
July 1, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#10
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28611730/exploiting-nanobodies-in-the-detection-and-quantification-of-human-growth-hormone-via-phage-sandwich-enzyme-linked-immunosorbent-assay
#11
Hossam Murad, Jana Mir Assaad, Rasha Al-Shemali, Abdul Qader Abbady
BACKGROUND: Monitoring blood levels of human growth hormone (hGH) in most children with short stature deficiencies is crucial for taking a decision of treatment with extended course of daily and expensive doses of recombinant hGH (rhGH or Somatropin(®)). Besides, misusing of rhGH by sportsmen is banned by the World Anti-Doping Agency and thus sensitive GH-detecting methods are highly welcome in this field. Nanobodies are the tiniest antigen-binding entity derived from camel heavy chain antibodies...
2017: Frontiers in Endocrinology
https://www.readbyqxmd.com/read/28192978/in-vitro-functional-quality-characterization-of-nota-modified-somatropins
#12
Nathalie Bracke, Han Yao, Evelien Wynendaele, Frederick Verbeke, Xiaolong Xu, Bert Gevaert, Alex Maes, Christophe Van de Wiele, Mike Sathekge, Sarah De Saeger, Bart De Spiegeleer
Chemical modifications on protein biopharmaceuticals introduce extra variability in addition to their inherent complexity, hence require more comprehensive analytical and functional characterization during their discovery, development, and manufacturing. Somatropin (i.e., recombinant human growth hormone, rhGH) modified with the chelating agent S-2-(4-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (p-SCN-Bn-NOTA) allows the incorporation of radiometals for research and possible theranostic purposes...
February 16, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28190647/human-growth-hormone-stabilizes-walking-and-improves-strength-in-a-patient-with-dominantly-inherited-calpainopathy
#13
Kira Philipsen Prahm, Ulla Feldt-Rasmussen, John Vissing
The aim was to investigate if daily low-dose treatment with recombinant human growth hormone (somatropine) can stabilize or improve muscle strength and walking capability in a patient with dominantly inherited calpainopathy. The patient was treated with daily injections of somatropine, except for a 6-month pause, over a period of 4.5 years. Efficacy was assessed by repeated muscle dynamometry tests and 6-minute walk tests (6MWT). Strength improved in most muscle groups on treatment, deteriorated in the 6-month off treatment, and improved again when treatment was resumed...
January 23, 2017: Neuromuscular Disorders: NMD
https://www.readbyqxmd.com/read/28161880/long-term-safety-and-efficacy-of-omnitrope-%C3%A2-in-adults-with-growth-hormone-deficiency-italian-interim-analysis-of-the-patro-adults-study
#14
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
June 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28105973/selective-determination-of-human-growth-hormone-somatropin-in-the-presence-of-its-chemical-degradation-products
#15
Mamdouh R Rezk, Marwa F Mohamed, Faten Abdelaziz Fathalla, Mostafa A Shehata
A rapid and sensitive HPLC method was developedand validated for selective determination of thehuman growth hormone (hGH) somatropin in thepresence of its deamidated and oxidized degradationproducts. Reversed-phase chromatographywith an acetonitrile and ammonium bicarbonatemobile phase in gradient elution mode was used.A short run time of 15 min allowed rapid andcost-effective analysis, with an average retentiontime of 7.4 min for native hGH, 6.2 min for itsdeamidated form, and 4.3 and 6 min for its oxidizedvariants...
January 19, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28003839/twin-arginine-translocation-system-in-secretory-expression-of-recombinant-human-growth-hormone
#16
Mohammad Reza Bagherinejad, Hamid Mir-Mohammad Sadeghi, Daryoush Abedi, C Perry Chou, Fatemeh Moazen, Mohammad Rabbani
Recombinant protein production in E. coli has several advantages over other expression systems. Misfolding, inclusion body formation, and lack of eukaryotic post translational modification are the most disadvantages of this system. Exporting of correctly folded proteins to the outside of reductive cytoplasmic environment through twin-arginine system could help to pass these limiting steps. Two signal sequences, TorA and SufI are used at N-terminal of human growth hormone (hGH) bearing DsbA gene sequence at C-terminal to enhance folding...
December 2016: Research in Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27888454/availability-and-quality-of-illegitimate-somatropin-products-obtained-from-the-internet
#17
Róbert György Vida, András Fittler, Ivett Mikulka, Eszter Ábrahám, Viktor Sándor, Ferenc Kilár, Lajos Botz
Background Growth hormones are widely available on the Internet for those who want to enhance their physical performance and improve body satisfaction. Illegitimate websites market somatropin injections without medical prescription and encourage misuse. Customers potentially put their health at risk when purchasing parenteral medications online. Objective The objective of our study was to evaluate the online market of no-prescription somatropin products and to analyse and document Internet pharmacy characteristics, distribution and pharmaceutical quality...
February 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#18
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
February 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27809913/long-term-safety-and-efficacy-of-omnitrope%C3%A2-a-somatropin-biosimilar-in-children-requiring-growth-hormone-treatment-italian-interim-analysis-of-the-patro-children-study
#19
MULTICENTER STUDY
Lorenzo Iughetti, Gianluca Tornese, Maria Elisabeth Street, Flavia Napoli, Claudia Giavoli, Franco Antoniazzi, Stefano Stagi, Caterina Luongo, Sara Azzolini, Letizia Ragusa, Gianni Bona, Clara Zecchino, Tommaso Aversa, Luca Persani, Laura Guazzarotti, Emiliano Zecchi, Alberto Pietropoli, Stefano Zucchini
BACKGROUND: PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope®, a somatropin biosimilar to Genotropin®, in children with growth disturbances. The primary endpoint of PATRO Children is long-term safety and the secondary endpoint is effectiveness, which is assessed by analysing auxological data such as height (HSDS) and height velocity (HVSDS) standard deviation scores...
November 3, 2016: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/27736009/the-effect-of-growth-hormone-gh-replacement-on-blood-glucose-homeostasis-in-adult-nondiabetic-patients-with-gh-deficiency-real-life-data-from-the-nordinet-%C3%A2-international-outcome-study
#20
Matthias M Weber, Beverly M K Biller, Birgitte Tønnes Pedersen, Effie Pournara, Jens Sandahl Christiansen, Charlotte Höybye
OBJECTIVE: To assess the effect of 4 years' growth hormone (GH) replacement on glucose homeostasis and evaluate factors affecting glycosylated haemoglobin (HbA1c ) in adults with growth hormone deficiency (GHD). DESIGN: NordiNet(®) International Outcome Study, a noninterventional study, monitors long-term effectiveness and safety of GH replacement [Norditropin(®) (somatropin), Novo Nordisk A/S] in real-life clinical practice. PATIENTS: Nondiabetic patients (n = 245) with adult-onset GHD (age ≥20 years at GH start), ≥4 years' GH replacement and HbA1c values at baseline and 4 years were included in the analysis...
February 2017: Clinical Endocrinology
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