Testing the Quality, Safety, and Efficacy of Insulin Biosimilars

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.

Quality, stability, sustainability, and the increased and thoughtful integration of artificial intelligence are foremost in the minds of those on the leading edge of testing trends.

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.