Biosimilars/Research
Biosimilars and non-medical switching among Saudi rheumatologists. The knowledge gap
The increasing cost of originator biologicals, combined with consequences of the COVID-19 pandemic, have burdened the healthcare system. Unfortunately, the biosimilar uptake in Saudi Arabia has not reached an optimal level despite the approval of several agents. Therefore, physicians are essential stakeholders in the process and acceptance of biosimilars.
The US needs to learn from Europe to increasing access to biosimilars
Europe has been leading the way when it comes to encouraging the use of biosimilars. This is especially true in Scandinavian countries, such as Norway, which are seen as leading the way when it comes to switching and substitution of biosimilars in Europe [1]. In fact, an analysis by Norwegian researchers has found that ‘tremendous savings’ could be realized in the US should the country implement similar strategies [2].
Real-world utilization of adalimumab biosimilar ABP 501
In a poster presentation at the virtual Crohn’s & Colitis Congress, which took place on 20‒22 January 2022, a study describing real-world utilization of adalimumab biosimilar ABP 501 in patients with inflammatory bowel disease (IBD) in Europe was presented [1].
The impact of insulin biosimilars on the diabetes landscape
The cost of diabetes care in the US continues to rise, with insulin accessibility and affordability a particular concern for providers and patients. Increased competition from increased availability of insulin biosimilars may help address these issues.
Differences in immunogenicity, pharmacovigilance and legal documents in biological products in Latin America
A study published in 2021 and carried out by Ramírez-Telles et al. examined the immunogenicity, pharmacovigilance and legal documentation of biological and biotechnological drugs as aspects required in the regulations for the registration of these products. This study was conducted in nine Latin American countries – Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama – that currently have a regulatory framework for their registration [1].
Biological standardization of bevacizumab: impact on global harmonization of potency assessment
Bevacizumab is a humanized monoclonal antibody (mAb) targeting vascular endothelial growth factor (VEGF), which causes excessive growth of new blood vessels from pre-existing ones in the form of angiogenesis, underlying pathology of cancers and intraocular neovascular diseases. Through binding to soluble VEGF, bevacizumab sterically blocks the interaction of VEGF with VEGF receptor 2 on endothelial cells and thereby interrupts the activation of downstream signalling for angiogenesis. Bevacizumab is indicated for the treatment of a range of cancers, including metastatic colorectal cancer, metastatic breast cancer and non-small-cell lung cancer. It is also used for off-label treatment of eye diseases including neovascular age-related macular degeneration and diabetic macular oedema.
Real-world data cannot replace post-approval confirmatory trials
A study published in JAMA Network Open [1] finds that real-world data are not sufficient to confirm the benefits of drugs approved by the US Food and Drug Administration’s (FDA) accelerated approval programme, and therefore cannot replace post-approval confirmatory trials.
Differences in clinical studies and pharmacovigilance of biological drugs in Latin America
Clinical studies are trials conducted in humans to test the efficacy of new drugs, devices, and other forms of treatment, as well as those already approved. On the other hand, preclinical or non-clinical studies are in vitro or in vivo studies, carried out on animals, which are necessary to evaluate the toxicity of the product and prove drug safety.
Regulations of the registration of biosimilars in Latin America
In the review and comparison of biosimilar products performed in the nine Latin American countries, particularities were found regarding their definition, as some regulations do not include the term, affecting the biosimilarity exercise and clinical and non-clinical information. In addition, differences were also found in aspects of their use, such as extrapolation of indications and automatic substitution or interchangeability. As for its labelling, further research by health authorities is required [1].
Biosimilar uptake and the education of healthcare provider
Affordability and access. Two simple words that nevertheless convey the complex burdens facing many healthcare systems around the world. And within the healthcare realm, there is likely no aspect that embodies issues related to affordability and access more than prescription medicines.
