Biologic drugs, large, complex molecules derived from living organisms with as many as tens of thousands of atoms per molecule, include vaccines, insulin, growth hormones, and monoclonal antibodies. Manufacturing these drugs is complicated and, unlike the process for small-molecule drugs, producing biologics cannot result in identical copies every time. When companies try to replicate a branded biologic, they must use similar but inevitably variant living organisms, resulting in a biosimilar.
In an article published in For the Defense, the publication of the Defense Research Institute, FaegreBD product liability attorneys Jessica Benson Cox, Munjot Sahu, Bridget Ahmann and Joe Price provided an in-depth explanation of biosimilar development in the U.S., and the implications it could have for product liability litigation.
“Carefully drafted FDA guidelines, still forthcoming, which take product liability concerns into consideration, will serve to reduce regulatory ambiguity that could lead to complex and expensive litigation for manufacturers and plaintiffs alike,” the article said.