Epoetin Biosimilars in Europe: Five Years On

Mikhail, Ashraf; Farouk, Mourad

doi:10.1007/s12325-012-0072-2

Cited by 41 publications

(34 citation statements)

References 27 publications

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“…It is interesting to note that there were no significant differences between the originator and biosimilar groups with regard to clinical characteristics at baseline, except that the patients undergoing therapy with biosimilar products were older than those who started with reference product. Moreover, as observed in other studies,25,33,34 this study showed no significant differences between the two groups in ΔHb levels 2 months after the initiation of treatment.…”

Section: Discussionsupporting

confidence: 87%

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Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

Perrone

Saragoni

Buda

et al. 2016

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AimThe purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products.MethodsAn observational retrospective study based on administrative and laboratory databases of three local health units was conducted. All adults diagnosed with hematological malignancies and who had received at least one epoetin (either reference product or biosimilars) prescription for the first time between 1 January 2010 and 30 April 2012 (enrollment period) were included. The date of the first prescription of epoetin within the enrollment period was defined as index date (ID). Patients were followed up for 4 weeks after ID (follow-up period) and were investigated for the 1-year period before the ID. The difference between the last hemoglobin (Hb) measurement after ID and the one prior to ID (ΔHb) was evaluated. The drug cost analysis was conducted from the perspective of the Italian National Health System.ResultsOverall, 69 patients were included in the study; 48 of them received reference epoetin product and 21 received biosimilars as first prescription. Among reference product users, the mean ± standard deviation (SD) age was 62.5±14.7 years; this cohort of patients was slightly significantly younger than the biosimilar users (71.8±11.8 years). The mean ± SD overall Hb level prior to treatment was lower among patients who started with biosimilar products (9.6±1.1 g/dL) compared to those who started with a reference product (10.1±2.1 g/dL). No significant differences in ΔHb were observed between biosimilar and originator groups during the followup period. The mean ± SD cost per patient was €667.98±573.93 and €340.85±235.73 for the reference product and biosimilar users, respectively (p=0.065).ConclusionOur study showed that the use of biosimilar products might contribute to controlling health care costs (in terms of drug treatments) for patients with hematological malignancies being maintained by high-quality anemia therapy. Our findings also showed some discordances regarding the most appropriate therapeutic approach in daily clinical practice.

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Section: Discussionsupporting

confidence: 87%

“…Since the expiration of patent protection, a number of novel biosimilar epoetins have been approved on the world market 23,25. Biosimilar medicines have significant potential to offer cost savings to health care providers, but the global value of a biosimilar is not determined entirely by its pricing 26.…”

Section: Discussionmentioning

confidence: 99%

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

Perrone

Saragoni

Buda

et al. 2016

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“…It has the same amino acid sequence as epoetin alfa (22,23). In a PK study comparing HX575 with branded epoetin alfa enrolling 80 healthy men, the pharmacodynamic (PD) results for the two agents were similar.…”

Section: Hx575 (Binocrit)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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“…Immunological reactions to a biologic drug are amongst the most important adverse reactions that are possible. While reactions can be simply developing antibodies with no clinical consequences, antibodies themselves can result in systemic immune reactions, autoimmunity to endogenous proteins or the undermining of therapeutic efficacy through antibodies targeting endogenous proteins [6]. Nephrologists are well aware of PRCA that occurred as a result of a formulation change of Eprex® introduced years after original marketing, despite the comparability exercises performed.…”

Section: Reviewmentioning

confidence: 99%

Potential Impact of Subsequent Entry Biologics in Nephrology Practice in Canada

Martinusen

Lo²,

Marin

et al. 2014

Can J Kidney Health Dis

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Purpose of reviewSubsequent entry biologics may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce health care costs, these agents pose unique challenges that must be met for successful implementation. Understanding the experiences around the globe in both regulatory affairs and implementation will be a valuable guide for Canadian clinicians. This report provides an executive summary of the information required to guide decisions to use or implement subsequent entry biologics by comparing Canadian regulations to other developed nations, discussing their clinical issues and predicting their impact on the Canadian market and nephrology practice. We hope that this review will assist clinicians and policy makers to navigate this complex subject and to make informed decisions in the best interest of their patients.Sources of informationSources of information include published literature and reports available in the public domain including guidelines obtained from regulatory agencies and information shared by Pharmaceutical companies. Lastly, we generated information from our own focus group consisting of nephrologists, a regulatory body representative, a hospital formulary representative, a patient representative, a hospital administrator, and a health economist.FindingsThere exists a common and robust approach in the G20 countries for approval and regulation of subsequent entry biologics. Although by definition these agents do not have advantages (other than costs) or disadvantages compared to the original biologic, there are potential concerns and economic uncertainties regarding their implementation. Where SEBs are on the market, their market share is variable and modest.LimitationsWe did not purchase third party reports for up to the minute marketing data. Since there are no subsequent entry biologics currently on the Canadian market, the information is only predictive.ImplicationsThe nephrology community will have to work with patients, payers, and regulatory bodies to ensure safe and effective use of subsequent entry biologics. Cost savings can be achieved but these agents should only be used after fully understanding their unique challenges. At this time, they should not be automatically substitutable and only used for Health Canada-approved indications. Only through good pharmacovigilence will health care providers and patients become better informed.

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Epoetin Biosimilars in Europe: Five Years On

Cited by 41 publications

References 27 publications

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

Potential Impact of Subsequent Entry Biologics in Nephrology Practice in Canada

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Epoetin Biosimilars in Europe: Five Years On

Cited by 41 publications

References 27 publications

Pharmacoutilization of epoetins in na&iuml;ve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

Pharmacoutilization of epoetins in na&iuml;ve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents

Potential Impact of Subsequent Entry Biologics in Nephrology Practice in Canada

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Product

Resources

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Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars