EMEA Guidelines on Biosimilars and Their Clinical Implications

Rossert, Jérôme

doi:10.1159/000107276

Cited by 10 publications

(8 citation statements)

References 11 publications

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“…Further, the biosimilar manufacturer must demonstrate analytical and preclinical biosimilarity of its product to the innovator biologic. Finally, to meet biosimilarity requirements, clinical studies are required for approval in the EU 16,17 .…”

Section: Comparability and Biosimilaritymentioning

confidence: 99%

Comparability and biosimilarity: considerations for the healthcare provider

Lee

Litten

Grampp

2012

Current Medical Research and Opinion

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Section: Comparability and Biosimilaritymentioning

confidence: 99%

Comparability and biosimilarity: considerations for the healthcare provider

Lee

Litten

Grampp

2012

Current Medical Research and Opinion

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“…Currently, epoetin zeta carries indications for treating symptomatic renal anemia, for intravenous (IV) and subcutaneous administration in adults and pediatric patients undergoing hemodialysis and in adult patients on peritoneal dialysis, or for those not yet undergoing dialysis 39,40. Contraindications include hypersensitivity, patients who develop epoetin-induced antibody-mediated pure red cell aplasia (PRCA) following treatment, uncontrolled hypertension, and patients who for any reason cannot receive adequate antithrombotic prophylaxis 39.…”

Section: Introductionmentioning

confidence: 99%

Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility

Davis–Ajami¹,

Wu²,

Downton³

et al. 2014

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Epoetin zeta was granted marketing authorization in October 2007 by the European Medicines Agency as a recombinant human erythropoietin erythropoiesis-stimulating agent to treat symptomatic anemia of renal origin in adult and pediatric patients on hemodialysis and adults on peritoneal dialysis, as well as for symptomatic renal anemia in adult patients with renal insufficiency not yet on dialysis. Currently, epoetin zeta can be administered either subcutaneously or intravenously to correct for hemoglobin concentrations ≤10 g/dL (6.2 mmol/L) or with dose adjustment to maintain hemoglobin levels at desired levels not in excess of 12 g/dL (7.5 mmol/L). This review article focuses on epoetin zeta indications in chronic kidney disease, its use in managing anemia of renal origin, and discusses its pharmacology and clinical utility.

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“…With EU patent time expiry, however, this will soon include the more structurally complex monoclonal antibody (mAb) therapies such as imatinib for CML, trastuzumab for HER2- overexpressing breast cancer, and rituximab for B-cell lymphoma. The market for these therapies is estimated at $36.4 to $40 billion [90, 91]. In preparation for those, the EMEA released draft guidelines for their biosimilar development in November 2011.…”

Section: Resultsmentioning

confidence: 99%

The economic pressures for biosimilar drug use in cancer medicine

Cornes

2012

Targ Oncol

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The main rationale for using biosimilar drugs is for cost saving. The market development for biosimilar drugs will therefore depend on the degree to which cost saving measures are required by nations, medical insurers and individuals and the absolute savings that could be gained by switching from original drugs. This paper is designed to discover the degree to which financial constraints will drive future health spending and to discover if legal or safety issues could impact on any trend. A structured literature search was performed for papers and documents to 27 August 2011. Where multiple sources of data were available on a topic, data from papers and reports by multinational or national bodies were used in preference to data from regions or individual hospitals. Almost all health systems face current significant cost pressures. The twin driver of increasing cancer prevalence as populations age and cancer medicine costs rising faster than inflation places oncology as the most significant single cost problem. For some countries, this is predicted to make medicine unaffordable within a decade. Most developed countries have planned to embrace biosimilar use as a cost-control measure. Biosimilar introduction into the EU has already forced prices down, both the price of biosimilar drugs and competitive price reductions in originator drugs. Compound annual growth rates of use have been predicted at 65.8% per year. Most developed countries have planned to embrace biosimilar use as a major cost-control measure. Only legal blocks and safety concerns are likely to act against this trend. For centralised healthcare systems, and those with a strong tradition of generic medicine use, biosimilar use will clearly rise with predictions of more than 80% of prescriptions of some biologic drugs within 1 year of market entry in the USA. Delaying the implementation of such programmes however risks a real crisis in healthcare delivery for many countries and hospitals that few can now afford.

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EMEA Guidelines on Biosimilars and Their Clinical Implications

Cited by 10 publications

References 11 publications

Comparability and biosimilarity: considerations for the healthcare provider

Comparability and biosimilarity: considerations for the healthcare provider

Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility

The economic pressures for biosimilar drug use in cancer medicine

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