Overview of Biosimilar in Pharmacovigilance

Abstract

The way we treat cancer patients has changed a lot over the few decades. This is because we now have biologic therapies, which're medicines that have helped cancer patients a lot. However these biologic therapies are very expensive to make which means that many cancer patients cannot afford them. Now that the patents for many of these biologic drugs have expired we have something called biosimilars. Biosimilars are helping to make cancer treatment more affordable for cancer patients. Biosimilars are made to be very similar to the drugs they have the same molecular structure and work in the same way and they are just as safe as the biologic drugs.Even though biosimilars are very similar to the biologic drugs we still need to keep an eye on how safe they're when cancer patients use them. This is where pharmacovigilance systems come in they help us find out if there are any problems with these medicines after they have been approved.This study looked at the safety of monoclonal antibodies which're biologic therapies used to treat cancer. We compared them to the drugs and we used data from the EudraVigilance database, which covered two years from 1 January 2021 to 31 December 2022.
We found that most of the problems reported with biosimilars were not serious they were the kinds of problems that we see with the biologic drugs. So our study shows that biosimilars are just as safe as the biologic drugs, which means that biosimilars can be an alternative to the biologic drugs. They can help cancer patients get the treatment they need at a cost.