Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.

This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients.

Objective: European healthcare systems face increasing pressures from ageing populations, chronic disease burdens, and rising costs. North Macedonia experiences similar challenges, including workforce shortages, limited economic growth, and persistent health inequalities. Although reforms such as the Diagnosis-Related Group payment system and the development of an e-health platform represent progress, major gaps remain: low public funding, high out-of-pocket spending, weak primary care, and poor data integration. This review analyses Value-Based Healthcare implementation in selected European countries and assesses the current state of the Macedonian health system to identify challenges and opportunities for Value-Based Healthcare.Methods: A two-step narrative approach was applied. Peer-reviewed literature on Value-Based Healthcare implementation in European countries was retrieved from PubMed, Scopus, and Web of Science, complemented by case studies and EIT Health handbook. To evaluate North Macedonia, policy documents and reports were reviewed from the World Health Organization, the European Observatory on Health Systems and Policies, the European Commission, and national authorities, including the Health Insurance Fund, the Institute of Public Health, and the Ministry of Health. Evidence was synthesized thematically across financing, digital infrastructure, outcome measurement, and governance.Results: Examples from Spain, the Netherlands, and Germany demonstrate the benefits of outcome measurement, integrated care delivery, and innovative payment models. Experiences from Bulgaria and Slovenia, with comparable health systems, provide additional lessons.Conclusion: Value-Based Healthcare implementation in North Macedonia will require greater public investment, stronger primary care, standardised outcome measurement, and robust digital infrastructure. Prioritising value-driven, patient-centered reforms could strengthen performance, equity, and sustainability.

The outbreak of the COVID-19 pandemic has generated the largest global health crisis of the 21st century, evolving into accelerating socioeconomic disruption. In spite of all rapidly and widely emerging scientific data on epidemiology, diagnosis, prevention and treatment of the COVID-19 disease, severe acute respiratory coronavirus 2 (SARS-CoV-2) is continuing to propagate in lack of definitive and specific therapeutic agents. Current therapeutic strategies are mainly focused on viral inhibition by antiviral drugs and hampering the exuberant immune response of the host by immunomodulatory drugs. In this review, we have studied the reports of the largest clinical trials intended to COVID-19 treatment published during the first year of the pandemics. In general, these results concentrate on seven therapeutic options: remdesivir, chloroguine/hydroxychloroquine, lopinavir-ritonavir combination, corticosteroids, tocilizumab, convalescent plasma and monoclonal antibodies. In line with the reviewed data, as of January 2021, most of the evidence support the use of remdesivir in hospitalized patients with moderate and severe forms of the disease and provide reliable data on the substantial beneficial effect of corticosteroids in patients requiring supplemental oxygen. Moreover, preliminary RECOVERY trial results have demonstrated the efficacy of tociluzumab in the treatment of critically ill patients. The reports presenting the outcomes of the other immune-based therapies under investigation are enthusiastically awaited.

The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.

The implemented actions to minimize the spread of the COVID-19 pandemic had a powerful effect on the transmission of other respiratory viruses, particularly influenza viruses. Influenza is a disease of viral aetiology that causes epidemics and occasionally pandemics during the wintertime almost every year. Generally, it is a mild and self-limiting disease, but it can represent high morbidity and even mortality when affecting the elderly population or people with latent chronic diseases. The existing circumstances of a persistent and ongoing epidemic caused by the SARS-CoV-2 virus, increase the probability of having active coincidence with the anticipated annual epidemic of influenza. Thus, the key is a logistic strategy for clinical and viral diagnosis of the SARS-CoV-2 virus that will determine the importance of understanding the role of influenza vaccines in virus-induced COVID-19 disease. This paper aims to compare the potential impact of the COVID-19 pandemic on the vaccination coverage of the population with the influenza vaccine. The official data for seasonal influenza vaccination were used, obtained from the weekly reports on the influenza situation in the Republic of North Macedonia from the Institute of Public Health as well as the data from the national system “MojTermin” for total vaccinated individuals with influenza vaccine for the season 2020/2021 and 2021/2022 including the 5th week. The analyzed data for the season 2021/2022 show an increase of applied doses by 8.3% compared to the season 2020/2021 and an increase of 11.5% compared to the season 2019/2020. Regarding the target groups in the season 2021/2022, including the 5th week, the coverage of influenza vaccination in children aged 6 months to 5 years has a significant decrease of 87.9% compared to the season 2020/2021. There is an increase in coverage in health professionals by 24.3% compared to last season, in the chronically ill the decrease of the applied doses is by 11.4% compared to last season, and in the elderly, over 65 it is noticeable an increase in coverage by 100% compared to the 2020/2021 season. Furthermore, there is a significant decrease of 95.7% in the vaccines administered to pregnant women compared to last season. The reduced coverage of influenza vaccination is partly due to the ambiguities arising from the influenza immunization campaign, which emphasized the importance of receiving a vaccine to minimize the spread of the influenza virus as an additional threat to the presence of COVID-19. Although the influenza vaccine does not protect against COVID-19, influenza vaccination has been part of the public health strategy to flatten the disease curve caused by respiratory viruses that attack the respiratory system, to protect and preserve the health of healthcare professionals providing care to patients with COVID-19. Influenza vaccination is still the most efficient preventive measure against influenza infections at our disposal and it is recommended by the most expert bodies including CDC, WHO, ECDC, and the National Committee for Immunization of the Republic of North Macedonia.