Comprehensive Description of Biosimilars Regulatory Framework in Brazil | Chapter 5 | Pharmaceutical Research: Recent Advances and Trends Vol. 6

Biological products, also known as biopharmaceuticals, are medications derived from biological systems and then created utilizing contemporary biotechnological techniques. These biological products are very different from traditional synthetic drugs in several important respects. They are much larger and more complex molecules with inherent diversity therefore, different manufacturers cannot produce identical biological products, even with the same type of host expression system and equivalent technologies. Thus, legal follow-on biologics manufactured and marketed after patent expiration are usually referred to as biosimilars. Brazil is the ninth-largest economy in the world, and it boasts one of the biggest and most complicated healthcare systems in the region. The Brazilian Health Regulatory Agency (ANVISA) plays a pivotal role in shaping the biosimilar landscape, balancing innovation with safety, efficacy, and accessibility. Biosimilars are required to satisfy various regulatory requirements before being permitted to enter the market in various regions. Other issues that are related to this need to be established by national authorities. These issues include interchangeability, labeling, and prescription information. The Brazilian health monitoring agency follows the fundamental criteria established by the World Health Organization for evaluating bio-similarity; nevertheless, it does not make use of the name "biosimilar." The objective of this article is to present the Brazilian biosimilar law.

 

Author (s) Details

Kethareshwara Sujatha Deeksha
Department of Pharmaceutics, Center of Excellence in Regulatory Science, JSS College of Pharmacy, Mysuru, Karnataka, India.

 

Balamuralidhara Veeranna
Department of Pharmaceutics, Center of Excellence in Regulatory Science, JSS College of Pharmacy, Mysuru, Karnataka, India.

 

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v6/1829

Quality Assessment of Clinical Practice Guidelines (CPG) for Management of Paediatric Dental Emergencies Applicable (PDEA) during COVID-19 Pandemic | Chapter 9 | Current Practice in Medical Science Vol. 9

 Utilizing the measurement tool AGREE II, the current study assesses the effectiveness of Clinical Practice Guidelines (CPG) for the COVID-19 pandemic's care of paediatric dental emergencies (Appraisal of Guidelines for Research and Evaluation in Europe).

We did a comprehensive web search for CPG among the best CPG compilers. In order to discover CPG that meet the inclusion criteria, a thorough search was also done among the major national and worldwide dental organisations as well as reliable websites.

According to AGREE II, five (05) out of the twenty-three (23) selected CPG were rated as "acceptable." The "Recommendation degree" of these five guides was assessed.

The AUGE clinical guide for ambulatory dental emergencies—Chile, 2011—was the only CPG that met the quality evaluation criteria and recommendation degree of the AGREEII instrument, and it was exclusively relevant to Spanish-speaking countries. It would be wise to write this manual in English since it is a universal tongue. Using the AGREE II quality assessment and recommendation degrees criteria, high, average, and low quality CPG were identified. Only one CPG received the label "highly recommended" with a score of 75% or higher. Therefore, it is proposed that both current and future CPG updates develop them utilising the available tools and methods in order to ensure their quality.

Author(s) Details:

Jessica Arieta-Miranda,
Faculty of Dentistry, National University of San Marcos. 375 German Amezaga Avenue, Lima, 15081, Peru.

Abad Salcedo Alcaychahua,
Scientific University of the South, Carretera Panamericana Sur 19, Villa EL Salvador, Lima, 15067, Peru.

Gary Pereda Santos,
Department of Second Specialty in Orthodontics and Maxilar Orthopedics, Faculty of Dentistry, National University of San Marcos, 375 German Amezaga Avenue, Lima, 15081, Peru.

Manuel Chavez Sevillano,
Department of Paediatric Stomatology, Faculty of Dentistry, National University of San Marcos. 375 German Amezaga, Lima, 15081, Peru.

Rosa Lara Verastegui,
Faculty of Dentistry, National University of San Marcos, 375 German Amezaga Avenue, 15081, Peru.

Daniel Blanco Victorio,
Cayetano Heredia Peruvian University, 430 Honorio Delgado Avenue, San Martín de Porres, Lima, 15102, Peru.

Gilmer Torres Ramos,
Department of Paediatric Stomatology, Faculty of Dentistry, National University of San Marcos. 375 German Amezaga, Lima, 15081, Peru.

Please see the link here: https://stm.bookpi.org/CPMS-V9/article/view/8016