The Role of PD Biomarkers in Biosimilar Development – To Get the Right Answer One Must First Ask the Right Question
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2753
Abstract: The potential for pharmacodynamic (PD) biomarkers to improve the efficiency of biosimilar product development and regulatory approval formed the premise for the virtual workshop Pharmacodynamic Biomarkers for Biosimilar Development and Approval hosted by the US… read more here.
Keywords: development; biosimilar development; biomarkers biosimilar; ask right ... See more keywords
Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance
Sign Up to like & getrecommendations! Published in 2022 at "Expert Review of Clinical Pharmacology"
DOI: 10.1080/17512433.2022.2034498
Abstract: ABSTRACT Objectives The current study is aimed at proposing a standardized regulatory model for biosimilar development and approval for adoption by BRICS-TM agencies, based on evaluation of regulatory guidelines and potential solutions to challenges. Methods… read more here.
Keywords: brics countries; review; development; biosimilar development ... See more keywords
Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities
Sign Up to like & getrecommendations! Published in 2021 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2021.726660
Abstract: Background: The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) on the… read more here.
Keywords: member countries; regulatory agencies; biosimilar development; marketing authorisation ... See more keywords