Biosimilars in 3D

Abraham, Ivo; Sun, Diana; Bagalagel, Alaa; Altyar, Ahmed E.; Abdulaziz, Mohammed; Tharmarajah, Soba; MacDonald, Karen

doi:10.4161/bioe.25067

Cited by 14 publications

(9 citation statements)

References 15 publications

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“…The clearing of all EPO results in severe anemia requiring blood transfusion intervention 77. However, epoetin zeta shows a different immunogenicity profile,48 mitigating the likelihood of PRCA 41,52…”

Section: Pharmacologymentioning

confidence: 99%

“…Overall, the biosimilar epoetin zeta shows tolerable adverse effects in patients with renal anemia compared to the reference product epoetin alfa 52,89. However, regulations require a detailed risk management plan to monitor serious and severe safety events and unknown potential safety issues for pharmacovigilance 77.…”

Section: Safetymentioning

confidence: 99%

“… 77 However, epoetin zeta shows a different immunogenicity profile, 48 mitigating the likelihood of PRCA. 41 , 52 …”

Section: Pharmacologymentioning

confidence: 99%

“…The complex molecular structure, as well as other issues including formulation and manufacture, results in biosimilars being similar to the referent product but not identical. However, biosimilars demonstrate comparable pharmacokinetics and therapeutic equivalence to the reference product 33,45,52–54. Minor differences in the microheterogeneity pattern of the molecule between the reference product and biosimilar are acceptable only when the difference does not impact safety and efficacy 55…”

Section: Introductionmentioning

confidence: 99%

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

Davis–Ajami¹,

Wu²,

Downton³

et al. 2014

BTT

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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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Section: Pharmacologymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

“… 77 However, epoetin zeta shows a different immunogenicity profile, 48 mitigating the likelihood of PRCA. 41 , 52 …”

Section: Pharmacologymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Davis–Ajami¹,

Wu²,

Downton³

et al. 2014

BTT

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show abstract

“…The Europeans Medicines Agency (EMA) define a biosimilar as a product that proves a high level of similarity with the reference product in an extensive comparability exercise with regards to its quality, safety and efficacy in addition to evidence of bioequivalence. 5 Accordingly, CT-P10 received regulatory approval for all therapeutic indications of the originator Rituximab and these include Rheumatoid arthritis (RA), non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) and granulomatosis with polyangiitis. 6 The approval of biological biosimilars and those of monoclonal antibodies represents a huge and significant economic opportunity to health authorities worldwide as these molecules will generate a significant price reduction and consequently will reduce the overall cost of biological therapy which is considered a significant burden to national health expenditure.…”

Section: Introductionmentioning

confidence: 99%

<p>Budget Impact Analysis of Switching to Rituximab’s Biosimilar in Rheumatology and Cancer in 13 Countries Within the Middle East and North Africa</p>

Almaaytah¹

2020

CEOR

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Introduction Biosimilars of monoclonal antibodies are being rapidly developed and approved by public health regulatory authorities worldwide. These biosimilars are expected to bring significant budgetary savings to national governments and consequently increase patients’ accessibility to biological therapy. Rituximab has been used extensively for the treatment of cancer and rheumatoid disorders over the past two decades. New biosimilars of Rituximab have been developed and introduced into clinical practice. We have analyzed the budgetary impact and savings outcome of introducing Rituximab’s biosimilar into 13 countries within the Middle East and North Africa through the implementation of a budget impact analysis model. Methods Our model was based on a 1-year full uptake and switch scenario of the Rituximab’s biosimilar CT-P10. The model calculated the total number of patients based on the total national consumption of Rituximab per country. Accordingly, the model produced savings per each indication which were translated into the additional number of patients that would be permitted access to Rituximab’s therapy as a result of these savings. Results In our modeling scenario, the total projected savings that will result from the uptake of Rituximab’s biosimilar within the MENA region were estimated to be 46.59 million dollars. The cumulative savings in all 13 countries would allow access of Rituximab’s therapy for a total of 6589 patients which is equivalent to a 14% increase in the number of patients benefiting from Rituximab’s therapy. Conclusion The introduction of Rituximab’s biosimilar within the Middle East and North Africa region is associated with significant budgetary savings that will allow public national health authorities to reinvest such economic gains either in expanding access to Rituximab therapy or other costly lifesaving biologicals.

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State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists

Covic

Abraham

2015

Int Urol Nephrol

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The European Medicines Agency (EMA), under a strictly regulated pathway, has approved several biosimilar products since 2005, including biosimilar versions of the erythropoiesis-stimulating agent (ESA) epoetin alfa since 2007. Subsequent to these approvals, the use of biosimilar epoetin alfa in the management of renal anemia has grown steadily throughout Europe. With the enactment of the US Biologics Price Competition and Innovation Act of 2009, a US Food and Drug Administration regulatory approval process for biosimilars was legalized. Thus, biosimilar erythropoietin products are expected to be available for prescription in the USA by mid-decade, presumably at a price that is competitive with the originator brand-name reference products. In this paper, we describe the status of originator and biosimilar ESAs, review the clinical development and regulatory approval of biosimilar erythropoietins in Europe, and summarize relevant efficacy and safety information of biosimilar erythropoietins in relation to their reference products to provide a background for US nephrologists as they appraise biosimilar erythropoietins as treatment options for renal anemia. Key lessons learned from Europe are that (a) EMA-approved biosimilar erythropoietins have comparable efficacy and safety profiles to their reference product erythropoietin; (b) pharmacovigilance preapproval and postapproval are critical, especially with regard to immunogenicity and vascular thromboembolic events; (c) strict preapproval and postapproval requirements must guide the regulatory pathway for biosimilars; and (d) high-quality manufacturing and production processes must be established to ensure quality biosimilar products. The availability of biosimilar erythropoietins in the USA will provide nephrologists with alternative effective, and potentially more affordable, treatment options for patients with renal anemia.

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Biosimilars in 3D

Cited by 14 publications

References 15 publications

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

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

<p>Budget Impact Analysis of Switching to Rituximab’s Biosimilar in Rheumatology and Cancer in 13 Countries Within the Middle East and North Africa</p>

State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists

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