Biosimilars: Advantages & Challenges

Introduction A biosimilar product, as defined by USFDA, is “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” By 2020, the biosimilar market is expected to reach $15 billion booming market, which is thrice the presentmarket(Ragunadhan 2018).Latest additions to this category of drugs are…

EU IVDR 2017/746: Overview of Regulation Changes

The In Vitro medical devices faced the implementation of the European Community Directive 98/79/EC in 1998. The In Vitro Diagnostic Directive (IVDD) 98/79/EC has been now transformed to In Vitro Diagnostic Regulation (IVDR) 2017/746/EU. The official timeline for this transition phase to complete implementation is 5 years (26th May 2022). The current regulatory framework for…

INNOVATIONS IN PEER-REVIEW

Peer Review is the process of evaluation of manuscripts submitted for scientific publication in journals/books, pre-clinical or clinical study reports, research progress reports etc., by experts or peers with similar competence as manuscript authors. It plays a pivotal role in scholarly publications with objective to ascertain quality, reliability and credibility of the work reported in…