Objective: To systematically summarize and evaluate the findings of existing studies about patients' perceptions of biosimilars by assessing their attitudes and knowledge.
Methods: We conducted a systematic review of published studies concerning patients' perceptions of biosimilars, using databases of China National Knowledge Infrastructure, SinoMed, Web of Science, PubMed, Embase, and Cochrane Library. Two independent reviewers screened a total of 2197 Chinese or English papers published between 1 January 2018, and 1 October 2022. We assessed the quality of the included studies by applying the Joanna Briggs Institute appraisal tools.
Results: Forty-three studies were included in the review, with the majority originating from Europe (n = 22) and North America (n = 10). Of these studies, 37 were cross-sectional quantitative studies, three were quasi-experimental studies, and the remaining three were qualitative studies based on semi-structured interviews. The sample sizes of the included studies ranged from 9 to 6554 patients. Twenty-two out of 31 studies investigating patients' acceptance of biosimilars found that most participants expressed satisfaction with treatment using biosimilars. However, doubts about the clinical effects and regulatory approval pathway could negatively influence patients' attitudes. The majority of patients understood the economic advantages of biosimilars; however, some incorrectly connected lower prices with lower quality. Patients generally lacked knowledge about biosimilars. There were 6-51% of participants who were familiar with biosimilars, and 25-58% thought they did not know enough about biosimilars. Physicians, pharmacists, medicines agencies, academia, and patient associations were identified as the main sources of information on biosimilars for patients. Healthcare providers not informing or advising patients about switching may hinder patients from acquiring enough knowledge.
Conclusions: The majority of patients expressed satisfaction with treatment using biosimilars, but limited knowledge continued to impede their perceptions. Doubts about the clinical effects and regulatory approval pathway were identified as major factors that negatively influenced patients' attitudes towards biosimilars, while the impact of a price advantage was mixed. It is essential to maintain a focus on educating healthcare professionals about biosimilars, including their clinical outcomes and the regulatory pathway, which equips them to provide comprehensive and informed guidance to patients.
Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium. Despite significant declines in malaria-attributable morbidity and mortality over the last two decades, it remains a major public health burden in many countries. This underscores the critical need for improved strategies to prevent, treat and control malaria if we are to ultimately progress towards the eradication of this disease. Ideally, this will include the development and deployment of a highly effective malaria vaccine that is able to induce long-lasting protective immunity. There are many malaria vaccine candidates in development, with more than a dozen of these in clinical development. RTS,S/AS01 (also known as Mosquirix) is the most advanced malaria vaccine and was shown to have modest efficacy against clinical malaria in phase III trials in 5- to 17-month-old infants. Following pilot implementation trials, the World Health Organisation has recommended it for use in Africa in young children who are most at risk of infection with P. falciparum, the deadliest of the human malaria parasites. It is well recognised that more effective malaria vaccines are needed. In this review, we discuss malaria vaccine candidates that have progressed into clinical evaluation and highlight the most advanced candidates: Sanaria's irradiated sporozoite vaccine (PfSPZ Vaccine), the chemoattenuated sporozoite vaccine (PfSPZ-CVac), RTS,S/AS01 and the novel malaria vaccine candidate, R21, which displayed promising, high-level efficacy in a recent small phase IIb trial in Africa.
Biosimilars have been available in the USA for over a decade, and in Europe for almost two decades. In that time, biosimilars have become established in the treatment landscape for a wide range of diseases, facilitating patient access and affordability of healthcare. However, patients can still struggle to access biological therapies in some markets. There is a need to streamline the process of developing biosimilars without compromising their quality, safety, or efficacy. This opinion piece considers the efficiencies that could be achieved within the biosimilar approval process. In clinical trials for biosimilars, clinical efficacy endpoints have been shown to be less sensitive measures of biosimilarity than biochemical, biophysical, and biological functional assays. Additional clinical efficacy studies comparing potential biosimilars and reference products do not add information that is useful for regulatory purposes. Large clinical studies of biosimilars with immunogenicity endpoints are of limited value, given the quality control processes in place for all biologics, including biosimilars. The expectation for multiple-switch studies for US interchangeability designation should be reconsidered immediately, and the category should be eliminated in the future. As biosimilars are typically approved globally based on a single set of clinical trials, and all subsequent manufacturing changes are already carefully monitored by regulatory authorities, comparative pharmacokinetic testing of EU and US reference products is unnecessary. Manufacturers and regulators could take greater advantage of existing real-world evidence. Streamlining biosimilar development would enable biosimilar development of more and a wider variety of biological drugs, accelerating biosimilar development without impacting patient safety or effectiveness.
Janus kinase inhibitor (JAKi) medications are small-molecule drugs that affect intracellular signal transduction. They are highly effective oral medications that have been approved for the treatment of various rheumatic diseases, with rheumatoid arthritis being a key example of an autoimmune rheumatic disease. JAKi are oral-route medications that are alternatives to injectable biologic therapies, launched in the late 1990s. While most safety concerns with JAKi are similar to the biologics, there are many differences. New data on comparative safety of JAKi versus tumor necrosis factor inhibitors (TNFi) were recently published that led to new black box warnings by the US Food and Drug Administration (FDA) about cardiovascular and cancer risks and a label change for JAKi. This review summarizes the current published data with regards to the safety of JAKi, focused on rheumatic diseases. Specifically, any risk differences between agents or across different indications are discussed, as well as the risk factors for these adverse outcomes.
Background: Real-world data on early treatment of coronavirus disease 2019 (COVID-19) outpatients with newly approved therapies are sparse.
Aim: To explore the pattern of use of monoclonal antibodies (mAbs)/antiviral therapies approved for early COVID-19 treatment in non-hospitalized patients from England and Italy from December 2021 to October 2022.
Methods: Public national dashboards on weekly mAb/antiviral use and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnoses from the Italian Medicines Agency, the Italian National Institute of Health, National Health Service in England and the UK Government were explored. Prevalence of antiviral use in outpatients during the entire study period and every two weeks was calculated, as a whole and by class and compounds. An interrupted time-series (ITS) analysis was carried out to assess the impact of predominant SARS-CoV-2 variants over time on the prevalence of use of mAbs/antivirals in England and Italy.
Results: Overall, 77,469 and 195,604 doses of mAbs/antivirals were respectively administered to a total of 10,630,903 (7.3 per 1000) and 18,168,365 (10.8 per 1000) patients diagnosed with SARS-CoV-2 infection in England and Italy. Prevalence of use every two weeks increased from 0.07% to 3.1% in England and 0.9% to 2.3% in Italy during the study period. Regarding individual compounds, sotrovimab (prevalence of use, 1.6%) and nirmatrelvir/ritonavir (1.6%) in England, and nirmatrelvir/ritonavir (1.7%) and molnupiravir (0.5%) in Italy, reported the highest prevalence during a 2-week period. In the ITS analysis, the transition from Delta to Omicron variant predominance was associated with a significant increase in the use of sotrovimab, molnupiravir, remdesivir and nirmatrelvir/ritonavir in both England and Italy, with a reduction of other marketed mAbs. The extent of the increase was higher in England than in Italy for all these drugs except for nirmatrelvir/ritonavir.
Conclusions: In this dual nationwide study, the prevalence of use of mAbs/antivirals against SARS-CoV-2 for early outpatients' treatment increased slowly up to 2.0-3.0% of all patients diagnosed with SARS-CoV-2 infection in both England and Italy from December 2021 to October 2022. The trend of individual drug use varied in relation to predominant SARS-CoV-2 variants with some differences across countries. In line with scientific societies' guidelines, nirmatrelvir/ritonavir was the most frequently prescribed antiviral in both countries in the most recent period.
In recent years, machine learning (ML) techniques have garnered considerable interest for their potential use in accelerating the rate of drug discovery. With the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the utilization of ML has become even more crucial in the search for effective antiviral medications. The pandemic has presented the scientific community with a unique challenge, and the rapid identification of potential treatments has become an urgent priority. Researchers have been able to accelerate the process of identifying drug candidates, repurposing existing drugs, and designing new compounds with desirable properties using machine learning in drug discovery. To train predictive models, ML techniques in drug discovery rely on the analysis of large datasets, including both experimental and clinical data. These models can be used to predict the biological activities, potential side effects, and interactions with specific target proteins of drug candidates. This strategy has proven to be an effective method for identifying potential coronavirus disease 2019 (COVID-19) and other disease treatments. This paper offers a thorough analysis of the various ML techniques implemented to combat COVID-19, including supervised and unsupervised learning, deep learning, and natural language processing. The paper discusses the impact of these techniques on pandemic drug development, including the identification of potential treatments, the understanding of the disease mechanism, and the creation of effective and safe therapeutics. The lessons learned can be applied to future outbreaks and drug discovery initiatives.
The complement system is a crucial part of the innate immune response, providing defense against invading pathogens and cancer cells. Recently, it has become evident that the complement system plays a significant role in anticancer activities, particularly through complement-dependent cytotoxicity (CDC), alongside antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP). With the discovery of new roles for serum complement molecules in the human immune system, various approaches are being pursued to develop CDC-enhanced antibody therapeutics. In this review, we focus on successful antibody engineering strategies for enhancing CDC, analyzing the lessons learned and the limitations of each approach. Furthermore, we outline potential pathways for the development of antibody therapeutics specifically aimed at enhancing CDC for superior therapeutic efficacy in the future.
Background: Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.
Objective: The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays.
Methods: In vitro assays such as receptor binding, receptor autophosphorylation, glucose uptake, and mitogenic potential were analyzed for biological characterization of BioGenomics recombinant insulin aspart (BGL-ASP) manufactured by BioGenomics Limited and NovoRapid® as the reference medicinal product (RMP) manufactured by Novo Nordisk. Insulin receptor binding was studied by a state-of-the-art method, surface plasmon resonance (SPR) for biomolecular interactions. The receptor autophosphorylation assay measures the phosphorylated insulin receptor in cell lysates. The glucose uptake assay measures the uptake of glucose by 3T3-L1 cells in the presence of insulin. Lipogenesis was studied in treated 3T3-L1 cells by detecting the accumulation of lipid droplets in the cells. Mitogenic effect was studied by cell proliferation assay using MCF-7 cells. A rabbit bioidentity test was performed by measuring the sudden decrease in blood glucose in the presence of insulin.
Results: The binding studies showed that the affinity of BGL-ASP was highly comparable to NovoRapid®. Insulin receptor autophosphorylation, glucose uptake, and lipogenesis demonstrated high similarity to the RMP. The mitogenic assay for BGL-ASP did not show any proliferative effect and was comparable to the RMP. The in vivo bioidentity test showed that the BGL-ASP is highly similar to the innovator, NovoRapid®.
Conclusion: The biological characterization studies of BGL-ASP demonstrated high binding and functional similarity to NovoRapid®.
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