The landscape of biosimilars in Saudi Arabia: preparing for the next decade.

INTRODUCTION: The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs. AREAS COVERED: We describe the current and future biosimilar landscape in KSA. We discuss the growth of the biosimilar market, the regulatory approval process, biosimilar adoption, and the potential impact on health-care systems and patient outcomes. EXPERT OPINION: The biosimilar market in KSA is expanding and expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by health-care providers. Overall, the biosimilar regulation is evolving and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost saving for the health-care system.

Prevalence of three-rooted mandibular permanent first and second molars in the Saudi population.

INTRODUCTION: This study aims to explore the frequency and factors affecting the prevalence of an extra root in the lower first and second permanent molars in the Saudi population. METHODS: Images of 379 Saudi patients who underwent CBCT for routine dental treatment were assessed. The CBCT images were evaluated on a 34-inch LED screen in a dark room and assessed by two examiners to count the prevalence of an additional root in the lower molars. Laterality and the gender factors were used to analyze that prevalence. Percentages represent categorical variables; Fisher's exact test and Chi square test were also used for the categorical variables. RESULTS: In the lower first molars, the prevalence of extra root in female patients was 5.7%, 3% in male patients and the overall prevalence was 3.05%; in lower second molars, the prevalence was 1.81% in female patients and 3.04% in male patients with an overall prevalence of 1.48%. A statistically significant difference was fond in the existence of an additional root with regard to laterality, to be more common on the right compared to the left side for both mandibular molars. The extra root prevalence was statistically significant in female patients at the first molar compared to male patients (p < 0.05). CONCLUSION: The overall of extra roots prevalence in the lower first and second molars in the Saudi population are 3.05% and 1.48%, respectively. Consideration and identification of this variation is essential to ensure successful endodontic treatment.

Fetal cardiotocography monitoring using Legendre neural networks.

A new technique for electronic fetal monitoring (EFM) using an efficient structure of neural networks based on the Legendre series is presented in this paper. Such a structure is achieved by training a Legendre series-based neural network (LNN) to classify the different fetal states based on recorded cardiotocographic (CTG) data sets given by others. These data sets consist of measurements of fetal heart rate (FHR) and uterine contraction (UC). The applied LNN utilizes a Legendre series expansion for the input vectors and, hence, has the capability to produce explicit equations describing multi-input multi-output systems. Simulations of the proposed technique in EFM demonstrate its high efficiency. Training the LNN requires a few number of iterations (5-10 epochs). The applied technique makes the classification of the fetal state available through equations combining the trained LNN weights and the current measured CTG record. A comparison of performance between the proposed LNN and other popular neural network techniques such as the Volterra neural network (VNN) in EFM is provided. The comparison shows that, the LNN outperforms the VNN in case of less computational requirements and fast convergence with a lower mean square error.

Transcriptome Analysis of CHO Cell Size Increase During a Fed-Batch Process.

In a Chinese Hamster Ovary (CHO) cell fed-batch process, arrest of cell proliferation and an almost threefold increase in cell size occurred, which is associated with an increase in cell-specific productivity. In this study, transcriptome analysis is performed to identify the molecular mechanisms associated with this. Cell cycle analysis reveals that the cells are arrested mainly in the G0 /G1 phase. The cell cycle arrest is associated with significant up-regulation of cyclin-dependent kinases inhibitors (CDKNs) and down-regulation of cyclin-dependent kinases (CDKs) and cyclins. During the cell size increase phase, the gene expression of the upstream pathways of mechanistic target of rapamycin (mTOR), which is related to the extracellular growth factor, cytokine, and amino acid conditions, shows a strongly synchronized pattern to promote the mTOR activity. The downstream genes of mTOR also show a synchronized pattern to stimulate protein translation and lipid synthesis. The results demonstrate that cell cycle inhibition and stimulated mTOR activity at the transcriptome level are related to CHO cell size increase. The cell size increase is related to the extracellular nutrient conditions through a number of cascade pathways, indicating that by rational design of media and feeds, CHO cell size can be manipulated during culture processes, which may further improve cell growth and specific productivity.

Transcriptome analysis for the scale-down of a CHO cell fed-batch process.

Transcriptome and metabolism analysis were performed to evaluate the scale-down of a CHO cell fed-batch process from a 10 L bioreactor to an ambr 15® (ambr) system. Two different agitation scale-down principles were applied, resulting in two different agitation rates in the ambr system: 1300 RPM based on the agitator tip speed, and 800 rpm based on the volumetric power input (P/V). Culture performance including cell growth, product titer, glycosylation, and specific consumption/production rates of metabolites was the same for both agitation rates in the ambr and was comparable to that of the 10 L system. The initial variation in gene expression between the inocula for the ambr and 10 L system was no longer present after three days of culture, indicating comparable culture conditions in both systems. Based on principal component analysis, changes in gene expression over time were similar between both scales with less than 6% variation. 2455 genes were uniquely regulated in the ambr system compared to 1604 genes in the 10 L system. Functional analysis of these genes did not reveal their relations with scale or cellular function. This study further strengthens that the ambr system gives representative culture performance for the 10 L bench-scale bioreactor.