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
Responsiveness to erythropoiesis-stimulating agents and renal survival in patients with chronic kidney disease
Conclusions
The study results suggest that hyporesponsiveness to ESA after the first 12-week administration as well as after 12 weeks is a risk for RD in pre-dialysis CKD patients. Furthermore, hyperphosphatemia and diabetic nephropathy are risk factors for RD. (Source: Clinical and Experimental Nephrology)
Source: Clinical and Experimental Nephrology - September 3, 2014 Category: Urology & Nephrology Source Type: research
Biosimilar esas: a comparative review
ConclusionBiosimilar products, such as epoetin zeta, may offer a range of features to patients, nurses and physicians, such as greater flexibility over dose and route of administration, in addition to greater access to biological medicines through cost savings.
Application to PracticeRenal nurses play a significant role in the management of patients with kidney disease and anaemia, not only having an important role in the delivery of medicine but also in the education of patients. This review discusses some of the practical aspects associated with the use of biosimilar medicines to assist nurses in making informed decision...
Source: Journal of Renal Care - September 1, 2014 Category: Urology & Nephrology Authors: Paul Wilson, Cheryl Wood Tags: Review Article Source Type: research
Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries
Future Oncology August 2014, Vol. 10, No. 9, Pages 1599-1609. (Source: Future Oncology)
Source: Future Oncology - August 22, 2014 Category: Cancer & Oncology Tags: article Source Type: research
Prospective, randomized, controlled, and open study in primarily inoperable, stage III non-small cell lung cancer (NSCLC) patients given sequential radiochemotherapy with or without epoetin alfa
Induction chemotherapy is associated with anemia in non-small cell lung cancer (NSCLC) patients undergoing radiotherapy. This randomized, open-label study compared the effect of sequential radiochemotherapy (RCHT) versus RCHT+epoetin alfa (RCHT+EPO), with respect to 2-year overall survival (OS). (Source: Radiotherapy and Oncology)
Source: Radiotherapy and Oncology - August 13, 2014 Category: Radiology Authors: Jürgen Debus, Peter Drings, Werner Baurecht, Ralf Angermund Tags: Phase III randomised trial Source Type: research
Prospective, randomized, controlled, and open study in primarily inoperable, stage III non-small cell lung cancer (NSCLC) patients given sequential radiochemotherapy with or without epoetin alfa.
CONCLUSIONS: A statistically non-significant trend for 2-year OS was observed in a sub-group of EPO-treated NSCLC-patients with baseline anemia, although this trend was not maintained in the overall population with inoperable NSCLC.
PMID: 25129551 [PubMed - as supplied by publisher] (Source: Radiotherapy and Oncology : journal of the European Society for Therapeutic Radiology and Oncology)
Source: Radiotherapy and Oncology : journal of the European Society for Therapeutic Radiology and Oncology - August 13, 2014 Category: Radiology Authors: Debus J, Drings P, Baurecht W, Angermund R Tags: Radiother Oncol Source Type: research
The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents.
Abstract
A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the ...
Source: Clinical Journal of the American Society of Nephrology : CJASN - June 26, 2014 Category: Urology & Nephrology Authors: Wish JB Tags: Clin J Am Soc Nephrol Source Type: research
Relative safety of peginesatide and epoetin alfa
ConclusionsRelative to administration of epoetin alfa, first administration of peginesatide in dialysis patients was acutely associated with higher risk of death or hospitalization as a result of cardiovascular morbidity or symptoms. Published 2014. This article is a U.S. Government work and is in the public domain in the USA. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - June 6, 2014 Category: Drugs & Pharmacology Authors: Eric D. Weinhandl, David T. Gilbertson, Allan J. Collins, Robert N. Foley Tags: Original Report Source Type: research
Reduction of transfusions in dialysis patients taking epoetin alfa in a placebo-controlled randomized clinical trial
(Source: American Journal of Kidney Diseases)
Source: American Journal of Kidney Diseases - April 14, 2014 Category: Urology & Nephrology Tags: National Kidney Foundation 2014 Spring Clinical Meetings Abstracts Source Type: research
Erythropoietin‐stimulating agents in the management of anemia of end‐stage renal disease patients on regular hemodialysis: A prospective randomized comparative study from Qatar
This study has specifically compared the effect of ESA type on the variability of serum hemoglobin levels in hemodialysis patients. Furthermore, it confirmed the efficacy and safety of once monthly CERA for maintaining tight hemoglobin control within recommended target ranges. (Source: Hemodialysis International)
Source: Hemodialysis International - April 1, 2014 Category: Hematology Authors: Fadwa Saqr Al‐Ali, Mohamed El‐Sayed Abdelfattah, Ashraf Ahmed Fawzy, Ahmed Farouk Hamdy, Aisha Elsayed Abdulla Tags: Original Article Source Type: research
Darbepoetin for the anaemia of chronic kidney disease.
CONCLUSIONS: Data suggest that darbepoetin alfa effectively reduces need for blood transfusions in adults with CKD stage 3 to 5, but has little or no effect on mortality or quality of life. The effects of darbepoetin alfa in adults with CKD stage 5D and kidney transplant recipients and children with CKD remain uncertain as do the relative benefits and harms of darbepoetin alfa compared with other ESAs (epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta).
PMID: 24683046 [PubMed - as supplied by publisher] (Source: Cochrane Database of Systematic Reviews)
Source: Cochrane Database of Systematic Reviews - March 31, 2014 Category: Journals (General) Authors: Palmer SC, Saglimbene V, Craig JC, Navaneethan SD, Strippoli GF Tags: Cochrane Database Syst Rev Source Type: research
RE: Adding Epoetin Alfa to Intense Dose-Dense Adjuvant Chemotherapy for Breast Cancer: Randomized Clinical Trial
(Source: JNCI)
Source: JNCI - March 26, 2014 Category: Cancer & Oncology Authors: Gross, I., Auerbach, M. Tags: Correspondence Source Type: research
Dose Efficiency of Erythropoiesis-Stimulating Agents for the Treatment of Patients With Chemotherapy-Induced Anemia: A Systematic Review.
CONCLUSIONS: Statistical heterogeneity between studies was high, although clinically the studies represented medical practice. Without randomized clinical trials directly comparing darbepoetin alfa and short-acting ESAs, these findings are tentative and future research is warranted. This review shows that good-quality, reliable data from head-to-head trials are lacking. The best available evidence comes from prospective ESA-arm data. Mean weekly doses, dose increases, and dose decreases suggest a dose efficiency for darbepoetin alfa compared with short-acting ESAs.
PMID: 24656152 [PubMed - as supplied by publisher]...
Source: Clinical Therapeutics - March 18, 2014 Category: Drugs & Pharmacology Authors: Forbes CA, Worthy G, Harker J, Kleijnen J, Kutikova L, Zelek L, Van Belle S Tags: Clin Ther Source Type: research
Anemia Management Trends in Hospital-Based Dialysis Centers (HBDCs), 2010 to 2013.
CONCLUSIONS: These study results support growing evidence that meaningful changes have occurred over the last 3 years in how anemia is clinically managed in US hemodialysis patients. Study limitations include that changes in patient clinical/demographic characteristics over time were not controlled for and that study findings may not be applicable to HBDCs that have different patient populations and/or do not use an electronic medical record system. Continuing to evaluate anemia management practices in HBDCs would provide additional information on the risks and benefits of anemia care. Consistent with national data, the fi...
Source: Clinical Therapeutics - February 27, 2014 Category: Drugs & Pharmacology Authors: Coritsidis GN, Maglinte GA, Acharya A, Saxena A, Chang CL, Hill J, Gitlin M, Lafayette RA Tags: Clin Ther Source Type: research
