Transformational changes in biologics, and in a complex era of emerging viruses, including Covid-19, and precision medicine, it is important to adapt various managerial, strategic and scientific methodologies in order to deal with the challenges ahead and underpin development.

Starting with insulin as the first recombinant therapeutic protein more than six decades ago, biologics have become the fastest-growing class of therapeutic compounds. They have provided treatment options for many people who suffer from some of the most serious medical conditions, such as rheumatoid arthritis, cancer, rare blood disorders, multiple sclerosis, diabetes, and HIV/AIDS.

There are currently nearly 100 approved antibodies and over 300  biologics available for human use. The demand is growing exponentially due to the fact these drugs have fewer adverse events than broadly acting drugs, and they can treat some indications that small molecule drugs have not been able to. However, about half of the biologics on the market are about to have their patents expire, which has led to the emergence of biosimilars.