In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or “biologics drugs” — drugs that are produced from living organisms or contain components of living organisms.(1) In 2018 alone, the U.S. FDA approved 17 biologics out of a total of 59 drugs – the highest number to date.(2)
Due to their ability to effectively treat complex health problems like cancer, infectious diseases, and autoimmune diseases, biologics have become a major focus for most pharmaceutical companies.(3) Additionally, the FDA facilitates approval of many biologics through expedited programs, making the ventures even more lucrative to Big Pharma. Last year, six of the 15 best-selling drugs were biologics.(4)
This article will delve into why the pharma industry is heading toward a biologics revolution, what challenges exist when developing these drugs to be efficacious but safe, and how novel analytical techniques can help circumvent these issues and optimize development.