Regulatory considerations in biosimilars: Asia pacific regions.

Biosimilars are the biological drugs that are granted after the expiry of the patent of an affirmed innovator. Asia Pacific countries are characterized by significant demand as they account for majority of the world population and poor affordability due to low per capita income in most regions. Some of these countries offer potential to emerge as global suppliers of affordable, safe and efficacious biosimilars. This article highlights the prospects of biosimilars in the Asia Pacific market. Regulatory framework in the various countries is also discussed.

Regulatory considerations in biosimilars: Middle East and Africa regions.

Biotherapeutic products whose patent protection has expired yield way to the development and approval of the more affordable "follow on medicines," known as biosimilars. These products need to have been shown as comparable in terms of quality, safety, and efficacy to the reference product (RP). In countries of the Middle East and Africa (MEA), there is a tremendous rise in deaths related to non-communicable diseases (NCDs). This class of diseases contributes to more than 38 million deaths worldwide annually, and they account for 74% of all deaths in MEA regions. The African continent consists of 54 countries, with each country having its own regulatory authority. To date, of the 54 African states, South Africa is the only country that has established a clear regulatory framework for biosimilar approval. This article highlights the prospects of biosimilars in the MEA market. The regulatory framework in the various MEA countries has also been discussed.

Regulatory considerations in biosimilars: Latin America region.

Development of biotherapeutic products has experienced steady growth over the past three decades. Expiration of patents on many biotherapeutics such as insulin, human growth hormone, and erythropoietin has opened the door for the development of biosimilars. The high cost of biotherapeutics has limited their accessibility, particularly in developing countries. Biosimilars offer the much- needed affordability and hence improved accessibility. Global agencies such as the World Health Organization are engaged in developing a prequalification program in order to help countries that do not have strong regulatory systems. This article summarizes the prospects of biosimilars in the Latin American market. Legal framework in various countries is also discussed.

Biosimilars in Developed Economies: Overview, Status, and Regulatory Considerations.

Biotherapeutics dominate the pipelines of pharmaceutical companies across the world today with products ranging from hormones, immune-modulators, monoclonal antibodies (mAbs), blood coagulation factors, enzymes and vaccines. However, they are considerably more expensive than their small molecule counterparts (pharmaceuticals) and as a result their contribution to the already unacceptably high healthcare costs in the developed economies (Europe, United States, Japan, Canada and South Korea) has been in the limelight in the last decade. This has resulted in the rise of biosimilars, seen as the affordable versions of innovator biotherapeutics. As the developed economies form the majority of the global sales of biotherapeutics, they are an attractive market for the biosimilars as well. Regulatory considerations for approval of biosimilars in these jurisdictions is likely to have a major impact on the adoption of biosimilars. In this paper, we offer a perspective on this topic while focusing on the developed markets. This article summarizes the main regulatory requirements for approval of biosimilars in Europe, United States, Japan, Canada, and South Korea. An overview on current biosimilars status and market in the aforesaid countries has also been included.

Antibacterial Effect of Two Novel Sealants: A Laboratory-Based Study.

Background: This research sought to assess the impact of polyhexamethylene guanidine hydrochloride (PHMGH) and 1,3,5-triacryloyl hexahydro-1,3,5-triazine (TAT) on the antibacterial activity of an experimental resin sealant. Materials and Methods: The two experimental sealants were formulated based on previous research, and Streptococcus mutans (S. mutans) was tested for biofilm and planktonic bacteria's antibacterial properties. In 48 hours, 300 L of frozen S. mutans in skim milk was stored in an oven at 37°C in a microaerophilic atmosphere with 5% of CO2 and put on a petri plate containing brain-heart infusion (BHI) broth with agar at 15 g/L. By combining 100 mL of the subculture broth with 900 mL of a sterile saline solution (0.9%) in an Eppendorf tube, the initial inoculum used for the experiments was evaluated. The colonies were measured in colony-forming units per milliliter (CFU/mL) after being counted visually. To measure the antibacterial activity, log CFU/mL was used to express the number of bacteria in the broth that had been in contact with the samples for 24 hours. Results: Outcomes of antibacterial activity against planktonic bacteria and against biofilm development on polymerized materials. The two innovative sealant materials were found to differ significantly from one another, while group 2's mean and standard deviation values were larger. Conclusion: Dental sealants designed with PHMGH and TCPTAT for anticaries application showed less bacterial growth throughout time the cavity prevention properties of the resin sealant.

Assessment of Oral Health Status and Treatment Needs of School Teachers in Indore City, Madhya Pradesh, India: A Cross-Sectional Study.

INTRODUCTION: Teachers are central to the well-being of a community. Being an influential part of society, their role can be broadened to promote oral health and healthy oral hygiene habits. This study was aimed at the assessment of the oral health status and treatment needs of school teachers in Indore City. METHOD: A descriptive cross-sectional study was carried out over a period of five months on 470 school teachers working in various government schools of Indore city selected through random sampling technique. The modified WHO Oral Health Assessment Form for Adults 2013 was used to record oral health status and treatment needs, while the WHO Questionnaire for Adults 2013 was used to document oral hygiene practices, dietary habits, and deleterious habits. Data was analyzed using IBM SPSS Version 25 (IBM Corp., Armonk, NY). Chi-square test, independent t-test, and one-way ANOVA were used. RESULTS: The gender distribution of the representative sample showed female predominance. The prevalence of smokeless tobacco consumption was 5.1% among the study subjects. The mean number of Decayed, Missing, and Filled Teeth (DMFT) was 3.45 ± 3.10, and the mean number of 1.52 ± 2.40 teeth showed the presence of bleeding. Around 37.2% had shallow pockets of 4-5 mm. A mean number of 4.26 ± 1.97 sextants showed 0-3 mm attachment loss. There was a significant association between the frequency and technique of toothbrushing with a decayed number of teeth (p<0.001). CONCLUSION: High proportion of dental caries and periodontal disease was seen which could be related to their oral health care-seeking behavior and the impairment related to age changes.

Infrared spectroscopic laser scanning confocal microscopy for whole-slide chemical imaging.

Chemical imaging, especially mid-infrared spectroscopic microscopy, enables label-free biomedical analyses while achieving expansive molecular sensitivity. However, its slow speed and poor image quality impede widespread adoption. We present a microscope that provides high-throughput recording, low noise, and high spatial resolution where the bottom-up design of its optical train facilitates dual-axis galvo laser scanning of a diffraction-limited focal point over large areas using custom, compound, infinity-corrected refractive objectives. We demonstrate whole-slide, speckle-free imaging in ~3 min per discrete wavelength at 10× magnification (2 µm/pixel) and high-resolution capability with its 20× counterpart (1 µm/pixel), both offering spatial quality at theoretical limits while maintaining high signal-to-noise ratios (>100:1). The data quality enables applications of modern machine learning and capabilities not previously feasible - 3D reconstructions using serial sections, comprehensive assessments of whole model organisms, and histological assessments of disease in time comparable to clinical workflows. Distinct from conventional approaches that focus on morphological investigations or immunostaining techniques, this development makes label-free imaging of minimally processed tissue practical.

Approval of biosimilars: a review of unsuccessful regulatory filings.

INTRODUCTION: Over the past three decades, biotherapeutics have transformed health care by offering effective treatments for complex diseases that were otherwise difficult to deal with via small molecule pharmaceuticals. Patents on several biotherapeutics have expired or are due to expire in recent times, and this has fueled the growth in biosimilars, products that are deemed to be similar to the already-approved innovator products in terms of safety and efficacy. Production of biosimilars is complicated by the fact that in biotech processes, the process is the product and there have been many instances where a small change in the manufacturing process results in significant undesirable clinical impact. This is why regulatory authorities around the world have formulated stringent guidelines for the approval of biosimilars. AREAS COVERED: This article aims to review unsuccessful regulatory filings for biosimilar approval. EXPERT OPINION: We have focused on regulatory submissions to EMA and FDA. Key shortcomings of the filings that failed to receive approval have been identified and discussed.

Knowledge, Attitude, and Practice of Upper-middle Class toward the Importance of a Pediatric Dentist.

AIMS AND OBJECTIVES: This study was carried out to assess the knowledge, attitude, and practice of upper middle class toward the importance of a pediatric dentist in the city of Amritsar, Punjab. MATERIALS AND METHODS: A cross-sectional study was carried out among the parents of children belonging to upper middle class in the city of Amritsar. This proposed study was assessed by the Institutional Ethical Committee (531/IDSR/2016) and their clearance was attained. A total of 950 parents were selected using a convenient sampling technique, and a self-made questionnaire was presented to them. Responses from the parents were evaluated in terms of numbers and percentages and were statistically analyzed using SPSS for Windows release 14.0 (SPSS Inc., Chicago, IL, USA). Differences at the 5% level were accepted as being statistically significant. RESULTS: The results of the study show limited knowledge about a pediatric dentist among the well-educated, well-placed, and economically sound citizens of Amritsar city. Consequently, the attitude and practices among this socioeconomic group are unconstructive and unprepared, respectively. CONCLUSION: Although the importance of taking a child to a pediatrician is a common practice among the upper and upper-middle classes of the society, it is clear that they do not give the same importance to a pediatric dentist, who is the pediatrician of dentistry.

Evaluation of the Impact of Oral Health Education on Oral Hygiene Knowledge and Plaque Control of School-going Children in the City of Amritsar.

AIMS AND OBJECTIVES: The present study aims to evaluate the impact of oral health education on oral hygiene knowledge and plaque control of school-going children in the city of Amritsar. MATERIALS AND METHODS: The study was carried out for 6 weeks and included four groups of schoolchildren of 10-12 years of age. Children were randomly selected and assigned into one of the four groups - Group I (verbal communication), Group II (verbal communication and self-educational pamphlets), Group III (audiovisual aids and verbal communication), and Group IV (control group). Oral health education was assessed by getting a questionnaire filled by children and plaque scores was recorded using Silness and Loe plaque index before and after the study. The data were then compared and analyzed using SPSS 16 software manufactured by IBM. RESULTS: Differences in knowledge gain after the dental health education were statistically significant between all the groups, except between Group II and Group III in which the difference was not found to be significant. Group III showed the highest decrease in plaque score followed by Group II. There was a significant difference in reduction in plaque scores between all the groups, except between the Groups II and III. CONCLUSION: Both methods, i.e., pamphlets and audiovisual aids when used along with oral lectures, are equally effective in improving the knowledge and plaque scores in children.