The Food and Drug Administration (FDA) has published draft guidance aimed at simplifying certain testing requirements for biosimilars, in a bid to accelerate their development and reduce the cost of biologic treatments. These medicines, made from living cells and used notably against cancer or autoimmune diseases, account for about 5% of prescriptions but represent 51% of pharmaceutical spending in the United States.

The agency is proposing, in particular, to scale back some pharmacokinetic studies when existing scientific data are deemed sufficient. According to the FDA, that move could cut the cost of those trials by up to 50%, or about $20m for developers. The goal is to make it easier for lower-cost versions of biologic medicines to reach the market; 82 biosimilars have already been approved in the United States.

The draft also envisages allowing companies, in some cases, to rely on clinical data from comparable versions of the reference medicine approved outside the United States. At the same time, the FDA has withdrawn guidance issued in 2015 on demonstrating biosimilar equivalence, saying it no longer reflects the agency's current approach after several years of experience evaluating these products.