The Experts below are selected from a list of 15948 Experts worldwide ranked by ideXlab platform
Pere Gascon - One of the best experts on this subject based on the ideXlab platform.
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Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
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epoetin Biosimilars in the treatment of chemotherapy induced anemia 10 years experience gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
Matti Aapro - One of the best experts on this subject based on the ideXlab platform.
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Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
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epoetin Biosimilars in the treatment of chemotherapy induced anemia 10 years experience gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
Andriy Krendyukov - One of the best experts on this subject based on the ideXlab platform.
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Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
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epoetin Biosimilars in the treatment of chemotherapy induced anemia 10 years experience gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
Martin Schiestl - One of the best experts on this subject based on the ideXlab platform.
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Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
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epoetin Biosimilars in the treatment of chemotherapy induced anemia 10 years experience gained
BioDrugs, 2018Co-Authors: Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere GasconAbstract:High-quality, safe, and effective Biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of Biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two Biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin Biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that Biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin Biosimilars. The now extensive European experience with Biosimilar epoetins should reassure regulators from other territories.
Steven Simoens - One of the best experts on this subject based on the ideXlab platform.
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European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption
BioDrugs, 2020Co-Authors: Liese Barbier, Steven Simoens, Arnold G. Vulto, Isabelle HuysAbstract:Background Despite the benefits offered by Biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, Biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about Biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching. Objective This study aims to provide recommendations on how to improve Biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe. Method The study consists of a structured literature review gathering original research data on stakeholder knowledge about Biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe. Results Although improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards Biosimilars among healthcare professionals and patients are identified in literature ( N studies = 106). Based on the provided insights from interviews with European experts ( N = 44), a number of challenges regarding Biosimilar stakeholder understanding are identified, including a lack of practical information about Biosimilars and their use, a lack of understanding about Biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind Biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about Biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical Biosimilar (switch) data, (5) share Biosimilar experiences by key opinion leaders and among peers, (6) provide practical Biosimilar product information, (7) provide guidance about Biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards. Conclusions This study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder Biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by Biosimilar competition.
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European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption.
BioDrugs : clinical immunotherapeutics biopharmaceuticals and gene therapy, 2020Co-Authors: Liese Barbier, Steven Simoens, Arnold G. Vulto, Isabelle HuysAbstract:Despite the benefits offered by Biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, Biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about Biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching. This study aims to provide recommendations on how to improve Biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe. The study consists of a structured literature review gathering original research data on stakeholder knowledge about Biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe. Although improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards Biosimilars among healthcare professionals and patients are identified in literature (N studies = 106). Based on the provided insights from interviews with European experts (N = 44), a number of challenges regarding Biosimilar stakeholder understanding are identified, including a lack of practical information about Biosimilars and their use, a lack of understanding about Biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind Biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about Biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical Biosimilar (switch) data, (5) share Biosimilar experiences by key opinion leaders and among peers, (6) provide practical Biosimilar product information, (7) provide guidance about Biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards. This study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder Biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by Biosimilar competition.
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European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice
BioDrugs, 2020Co-Authors: Liese Barbier, Steven Simoens, Arnold G. Vulto, Isabelle HuysAbstract:Background Despite the benefits Biosimilars offer in terms of cost savings and patient access, healthcare professionals and patients have been reluctant to use them. Next to insufficient understanding of and trust in Biosimilars, healthcare professionals and patients have questions about switching and the nocebo effect when using Biosimilars in clinical practice. In addition, clear motivation to use Biosimilars may be lacking among these stakeholders. Objective This study aims to provide recommendations on how to improve Biosimilar use on both a clinical and a practical level based on insights from healthcare professionals (physicians, hospital pharmacists, nurses), patients (or their representatives), and regulators across Europe. Methods We conducted 44 semi-structured interviews with experts from five stakeholder groups across Europe: physicians, hospital pharmacists, nurses, regulators, and patients/representatives. Interviews were transcribed ad verbatim and transcripts analysed according to the thematic framework method. Results Based on the insights and considerations of the experts interviewed, we identified a number of recommendations to improve the use of Biosimilars in clinical practice. Regarding switch implementation, the experts voiced support for the following actions: (1) disseminate evidence from and experience with (multiple) switching; (2) provide clear, one-voice regulatory guidance about the interchangeability of Biosimilars and their reference product; (3) apply a multi-stakeholder implementation and communication protocol to guide switching in clinical practice; (4) apply a pragmatic approach when taking switch decisions; and (5) avoid mandated switching, allowing stakeholder communication and alignment. When discussing approaches to increase the willingness of stakeholders to use Biosimilars, we concluded that actions should be centred on (1) communicating the benefits provided by Biosimilars and the introduction of market competition, (2) increasing awareness among stakeholders about medicine prices and their societal responsibility to use medicines in a cost-effective manner, (3) transparent reporting about the allocation of savings, (4) sharing Biosimilar usage data among hospitals and prescribers to allow peer-to-peer benchmarking, and (5) applying a balanced combination of tangible and non-tangible incentives that can be tailored to offset the time and effort expended by stakeholders when switching to a Biosimilar. Conclusions This study proposes a number of strategic, practical, and overarching recommendations to support healthcare professionals and inform decision makers to improve the clinical use of Biosimilars and the willingness of stakeholders to use them. The proposed solutions to fully realise the potential of Biosimilars for healthcare systems and patients include developing practical switch guidance, being transparent about the gains from Biosimilar use (and how savings are allocated), and developing a combination of non-tangible and tangible incentives for involved stakeholders.
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Biosimilar medicines and cost-effectiveness
ClinicoEconomics and outcomes research : CEOR, 2011Co-Authors: Steven SimoensAbstract:Given that Biosimilars are agents that are similar but not identical to the reference biopharmaceutical, this study aims to introduce and describe specific issues related to the economic evaluation of Biosimilars by focusing on the relative costs, relative effectiveness, and cost-effectiveness of Biosimilars. Economic evaluation assesses the cost-effectiveness of a medicine by comparing the costs and outcomes of a medicine with those of a relevant comparator. The assessment of cost-effectiveness of a Biosimilar is complicated by the fact that evidence needed to obtain marketing authorization from a registration authority does not always correspond to the data requirements of a reimbursement authority. In particular, this relates to the availability of adequately powered equivalence or noninferiority studies, the need for comparative data about the effectiveness in a real-world setting rather than the efficacy in a structured setting, and the use of health outcome measures instead of surrogate endpoints. As a Biosimilar is likely to be less expensive than the comparator (eg, the reference biopharmaceutical), the assessment of the cost-effectiveness of a Biosimilar depends on the relative effectiveness. If appropriately designed and powered clinical studies demonstrate equivalent effectiveness between a Biosimilar and the comparator, then a cost-minimization analysis identifies the least expensive medicine. If there are differences in the effectiveness of a Biosimilar and the comparator, other techniques of economic evaluation need to be employed, such as cost-effectiveness analysis or cost-utility analysis. Given that there may be uncertainty surrounding the long-term safety (ie, risk of immunogenicity and rare adverse events) and effectiveness of a Biosimilar, the cost-effectiveness of a Biosimilar needs to be calculated at multiple time points throughout the life cycle of the product.