Biosimilar uptake by British local formularies: a cross sectional study
Conclusion Although the market for biosimilars can act in parallel to the generic market, their uptake measured using local British formularies was less than what is expected given that the British market for medicines has a strong focus on generics. Finally, geographical variability within GB requires further investigation. (Source: International Journal of Clinical Pharmacy)
Source: International Journal of Clinical Pharmacy - September 4, 2017 Category: Drugs & Pharmacology Source Type: research
018 –Local Tolerability and Safety Profile of Somatropin (Recombinant Human Growth Hormone) in Pediatric Patients With Growth Hormone Deficiency or Turner Syndrome
Background: Somatropin is indicated for treatment of pediatric growth hormone deficiency (GHD) in the United States and for treatment of pediatric GHD and Turner syndrome (TS) in the European Union. (Source: Journal of Pediatric Nursing)
Source: Journal of Pediatric Nursing - May 1, 2017 Category: Nursing Authors: Mohita Kumar, Bradley Scott Miller, Kyriakie Sarafoglou Source Type: research
Long-term safety and efficacy of Omnitrope ® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study
ConclusionsThis study confirms the effectiveness and safety of Omnitrope® in adult patients with GHD in Italy. However, due to the limited size of the study population, these results need to be further confirmed by the global PATRO Adults study. (Source: Journal of Endocrinological Investigation)
Source: Journal of Endocrinological Investigation - February 3, 2017 Category: Endocrinology Source Type: research
Somatropin
(Source: Reactions Weekly)
Source: Reactions Weekly - December 31, 2016 Category: Drugs & Pharmacology Source Type: research
The effect of growth hormone (GH) replacement on blood glucose homeostasis in adult nondiabetic patients with GH deficiency: real ‐life data from the NordiNet® International Outcome Study
ConclusionsThese data demonstrate that 4 years’ GH replacement therapy did not adversely affect glucose homeostasis in the majority of adults with GHD. (Source: Clinical Endocrinology)
Source: Clinical Endocrinology - November 20, 2016 Category: Endocrinology Authors: Matthias M. Weber, Beverly M.K. Biller, Birgitte T ønnes Pedersen, Effie Pournara, Jens Sandahl Christiansen, Charlotte Höybye Tags: Original Article Source Type: research
Long-term safety and efficacy of Omnitrope ®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study
ConclusionsOmnitrope ® appears to be well tolerated and effective for the treatment of a wide range of paediatric indications, which is consistent with the outcomes from controlled clinical trials. These results need to be interpreted with caution until the data from the global PATRO Children study are available. (Source: Italian Journal of Pediatrics)
Source: Italian Journal of Pediatrics - November 2, 2016 Category: Pediatrics Source Type: research
Somatropin
(rDNA origin) is a human growth hormone produced by recombinant DNA technology. [#] (Source: Aids Info Drugs)
Source: Aids Info Drugs - February 16, 2016 Category: Drugs & Pharmacology Source Type: research
Reversible albumin-binding GH possesses a potential once-weekly treatment profile in adult growth hormone deficiency.
CONCLUSION: Four once-weekly doses of NNC0195-0092 (dose range 0.02-0.12 mg/kg) administered to adult patients with GHD were well tolerated and IGF-I profiles were consistent with a once-weekly treatment profile. No clinically significant safety and tolerability signals causally related to NNC0195-0092 were identified, nor were any immunogenicity concerns revealed.
PMID: 26727076 [PubMed - as supplied by publisher] (Source: The Journal of Clinical Endocrinology and Metabolism)
Source: The Journal of Clinical Endocrinology and Metabolism - January 4, 2016 Category: Endocrinology Authors: Rasmussen MH, Janukonyté J, Klose M, Marina D, Tanvig M, Nielsen LF, Höybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS Tags: J Clin Endocrinol Metab Source Type: research
Potential Public Resource Savings In Brazil: The Somatropin Case
Somatropin is provided in 4 and 12IU presentations by the Brazilian Unified Health System (SUS) for the treatment of Hypopituitarism (HP) and Turner Syndrome (TS). Other presentations are available in the market and are believed to provide a less costly treatment and/or less somatropin waste. (Source: Value in Health)
Source: Value in Health - October 23, 2015 Category: Global & Universal Authors: LL Lemos, MR Silva, JB Santos, Costa JD, RM Gomes, RC Nascimento, AM Almeida, AA Guerra Júnior Source Type: research
Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices
Abstract
Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals. Now, with the first biosimilar approval in the USA and many biosimilars expected to be lau...
Source: Drug Safety - June 25, 2015 Category: Drugs & Pharmacology Source Type: research
The uptake of Biosimilar products by British formularies
This study explored the uptake of biosimilars within GB formularies. (Source: Value in Health)
Source: Value in Health - May 1, 2015 Category: Global & Universal Authors: S. Alnahar, R. Elliott, M. Smith Source Type: research
Surface acoustic wave biosensor as a functional quality method in pharmaceutics
We present here an analytical quality by design (aQbD) based approach using somatropin (rhGH, recombinant human growth hormone) and derivatives as model biotechnological drugs and an antibody interaction partner to evaluate the functional quality. Using techniques described in ICH Q2, Q5 and Q8–11, we evaluated the performance of this SAW biosensor technique from a pharmaceutical quality point of view. CMAs (Critical Method Attributes) such as sensitivity, selectivity and variability are evaluated as a function of different experimental variables using DoEs (design of experiments). We suggest qualification tests as well ...
Source: Sensors and Actuators B: Chemical - January 12, 2015 Category: Chemistry 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
ConclusionThis 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 - December 1, 2014 Category: Drugs & Pharmacology Source Type: research
Legal and health variations in drug litigation injunctions granted in Minas Gerais
CONCLUSIONS There are significant differences in the granting of injunctions, depending on the procedural and clinical variances. Important trends in the pattern of judicial action were observed, particularly, in the reduced granting [of injunctions] over the period. OBJETIVO Investigar fatores relacionados ao deferimento de liminares por medicamentos. MÉTODOS Estudo descritivo retrospectivo dos processos judiciais por medicamentos em Minas Gerais, de outubro de 1999 a 2009. A base de dados, constituída por 6.112 ações judiciais, teve 6.044 com pedido de liminar e 5.167 com requisição de medicamentos. Foram exc...
Source: Revista de Saude Publica - November 21, 2014 Category: Global & Universal Source Type: research
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan
Publication date: September 2011 Source:Biologicals, Volume 39, Issue 5 Author(s): Teruyo Arato , Teruhide Yamaguchi To share the experience of reviewing clinical data required for the licensing of follow-on biologic products (biosimilar products and similar biotherapeutical products as EU and WHO terminology, respectively) in Japan, the data packages of two follow-on biologics, “Somatropin BS s.c. [Sandoz] (Omnitrope®)” and “Epoetin alfa BS [JCR]”, which have been recently approved in Japan according to the “Guidelines for the Quality, Safety and Efficacy Assurance of Follow-on Biologics” published on M...
Source: Biologicals - November 3, 2014 Category: Biology Source Type: research
