Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment

Wizemann, V.; Rutkowski, Bolesław; Baldamus, C. A.; Scigalla, P.; Koytchev, Rossen

doi:10.1185/030079908x273264

Cited by 72 publications

(96 citation statements)

References 28 publications

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“…Two of these investigated IV use, either for correction of anemia or as maintenance therapy [28,29]. In the correction phase study, patients were randomized to treatment with SB309 (n = 305) or epoetin alfa 166.14±109.85 IU/kg/week) [28].…”

Section: Safety and Efficacymentioning

confidence: 99%

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Epoetin Biosimilars in Europe: Five Years On

Mikhail

Farouk

2012

Adv Therapy

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Section: Safety and Efficacymentioning

confidence: 99%

“…T h e m a i n t e n a n c e s t u d y e n r o l l e d 313 hemodialysis patients with renal anemia who had received epoetin for ≥3 months [29]. Patients were randomized to receive one epoetin product for 12 weeks and then the other for an additional 12 weeks in a crossover design study.…”

Section: Safety and Efficacymentioning

confidence: 99%

Epoetin Biosimilars in Europe: Five Years On

Mikhail

Farouk

2012

Adv Therapy

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“…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. A recent third trial with SB309 (epoetin zeta) has documented the therapeutic equivalence of epoetin zeta to epoetin alfa for the s.c. route of administration in renal anemia.…”

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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“…Switching from SB309 to epoetin alfa reduced the dose required by approximately 10% and increased the Hb by about 10%. Applying the correction factor for the difference in protein content between the two agents placed the differences within a modified post hoc acceptance range from the studies by both Krivoshiev et al (28) and Wizemann et al (29). The long-term safety of SB309 was assessed by examining combined outcomes of 745 chronic hemodialysis patients who received the agent in the correction and maintenance studies noted above (28,29).…”

Section: Sb309 (Retacrit)mentioning

confidence: 99%

“…In a trial by Krivoshiev et al (28) comparing correction of anemia in dialysis patients with iv SB309 with epoetin alfa over 24 weeks, there was no difference in the Hb level achieved, but the mean epoetin dose during the last 4 weeks of treatment was approximately 10% higher with SB309 than with epoetin alfa. A maintenance study by Wizemann et al (29) randomized patients to receive epoetin alfa or SB309 for 12 weeks and then crossed them over to receive the other agent for an additional 12 weeks. Switching from epoetin alfa to SB309 increased the dose required by 10%-15% and transiently decreased the Hb level by about 5%.…”

Section: Sb309 (Retacrit)mentioning

confidence: 99%

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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Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment

Abstract: Epoetin zeta is therapeutically equivalent to epoetin alfa in the maintenance of target Hb levels in patients with renal anaemia. No unexpected AEs were seen.

Cited by 72 publications

References 28 publications

Epoetin Biosimilars in Europe: Five Years On

Epoetin Biosimilars in Europe: Five Years On

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

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

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