5 research outputs found

    “Plastics monitoRIng detectiOn RemedIaTion recoverY – PRIORITY”

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    The “Plastics monitoRIng detectiOn RemedIaTion recoverY – PRIORITY” Action aims to develop a research network focused on developing, implementing, and consolidating strategies to tackle the global challenge of micro- and nano-plastics environmental pollution. The Action will create a broad and skilled transdisciplinary network to establish a 360-degree view combining the partners’ expertise in chemistry, physics, life science, engineering, standards, economy, and law. This network will maximize the European competitiveness in creating a robust infrastructure for scientific communication, exchange, and collaboration to foster new research activities and citizen science. PRIORITY aims to enhance the technical standards for sampling and analysis of micro and nanoplastics in the environment, to develop a more reliable assessment of exposure and biological effects, and to advance activities in terms of remediation and recovery of the environment. The scientific community, economy and all the European citizens will benefit from the outcomes of the activities. One of the targets is the harmonization of the European regulation associated with microplastics related issues. The Action will then support European Commission regulations organisms in critical aspects of environmental and ecosystems protection, food safety, and life science

    Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina : findings and implications

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    Background: Monoclonal antibodies (mAbs) represent the most numerous and significant group of biotherapeutics. Whilst mAbs have undoubtedly improved treatment for many chronic diseases including inflammatory diseases, they are typically expensive for health care systems and patients. Consequently, access to mAbs has been a problem for many patients especially among Central and Eastern European (CEE) countries. However, biosimilars can potentially help with costs although there are concerns with their effectiveness and safety. This includes biosimilars for long-acting insulin analogues. Aim: Assess the availability and use of biological medicines including biosimilars within Bosnia and Herzegovina (B&H). Methods: Assess the availability of mAbs via the current lists of approved and accessed mAbs versus those licenced in Europe and the USA and their utilisation, as well as specifically insulin glargine and its biosimilars, within B & H. Results: The availability of the mAbs in B&H appears satisfactory, which is encouraging. However, current usage is limited to a few mAbs which is a concern for subsequent patient care especially with limited use of biosimilars to address issues of affordability. We also see limited use of biosimilar insulin glargine. Conclusion. The limited use of mAbs including biosimilars needs to be addressed in B & H to improve the future care of patients within finite resources. We will monitor these developments

    Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe : Findings and Implications

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    Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel. Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups. There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed

    The current situation regarding long-acting insulin analogues including biosimilars among african, Asian, European, and South American countries : findings and implications for the future

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    Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities
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