Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia

Baldamus, C. A.; Krivoshiev, S; Wolf-Pflugmann, Michael; Siebert-Weigel, Marianne; Koytchev, Rossen; Bronn, Angelika

doi:10.1007/s12325-008-0111-1

Cited by 38 publications

(25 citation statements)

References 19 publications

(28 reference statements)

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“…SB309 maintained target Hb levels with a constant dose. Approximately 5% of the adverse events were considered to be related to the study treatment, and they were consistent with those previously reported with all ESAs (30). In a post hoc analysis of the three studies above comparing SB309 with epoetin alfa, the incidence of adverse events was not significantly different between the two treatments (31).…”

Section: Sb309 (Retacrit)supporting

confidence: 84%

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

Wish

2014

Clinical Journal of the American Society of Nephrology

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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 Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well.

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Section: Sb309 (Retacrit)supporting

confidence: 84%

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

Wish

2014

Clinical Journal of the American Society of Nephrology

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“…As an example, there is evidence from the literature that epoetin zeta, administered intravenously, is therapeutically equivalent to epoetin alpha in the correction of low hemoglobin concentration in patients with CKD undergoing hemodialysis. [9,10] Binocrit Ò is not approved for subcutaneous (only for intravenous) administration in CKD and this factor may in theory discourage the use of this biosimilar in CKD patients because of increased discomfort for the patient. As a similarly low number of Retacrit Ò users with CKD was documented, a general skepticism of clinicians in using biosimilars rather than patients' discomfort may account for the low penetration of biosimilars in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

How Much are Biosimilars Used in Southern Italy?

Loiacono

Sgroi

Coppolino³

et al. 2012

BioDrugs

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“…10 Comparable efficacy and safety between the SB309 and Eprex ® was demonstrated in two randomized, doubleblind phase III clinical trials with intravenous administration, a correction phase and a maintenance phase study, involving 922 hemodialysis patients with renal anemia. 11,12 An additional maintenance treatment follow-up study was performed to obtain long-term safety data. 13 For both epoetins, there have been no reports of immunogenicity with the intravenous use of the drug.…”

Section: Appropriateness Of Use Of Biosimilar Epoetins In Practicementioning

confidence: 99%

Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation

Barosi¹,

Bosi²,

Abbracchio³

et al. 2011

Haematologica

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The term “biosimilars” (“follow-on biologics” in the USA) has been used by the European Medicines Agency (EMA) to describe officially-approved subsequent versions of innovator biotechnological products made by a different competitor after the patent and exclusivity rights have expired.1 Biosimilars pose a problem to the clinician who is bound to require guidance on how best to capitalize on these new pharmacological opportunities. In its mandate to promote the best hematologic care, the Italian Society of Hematology (SIE) and the affiliate societies SIES (Società Italiana di Ematologia Sperimentale) and GITMO (Gruppo Italiano Trapianto di Midollo Osseo) convened an expert panel to produce a position paper on the two marketed biosimilars in hematology, i.e. epoetin and filgrastim. The panel of 8 experts was selected according to the conceptual framework elements of the NIH Consensus Development Program.2 Panel bias was minimized by eliminating from consideration strong advocates for or against the use of biosimilars. Each panel member was asked to disclose any tie he or she may have had with pharmaceutical companies manufacturing the drugs considered in the paper in the last five years. The project was conducted independently from any pharmaceutical company which sold either conventional drugs or biosimilars

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Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia

Cited by 38 publications

References 19 publications

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

How Much are Biosimilars Used in Southern Italy?

Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation

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