FDA's New Guidance to Boost Biosimilar Drug Approvals

The U.S. Food and Drug Administration announced a plan on Wednesday to cut down the number of human clinical studies needed to approve certain biosimilar drugs, a move designed to slash development costs for these cell-based medicines.

According to U.S. Health Secretary Robert F. Kennedy Jr., this strategy forms part of a larger effort to reduce healthcare expenses, asserting that companies may bypass large trials if advanced testing proves biosimilars are equally effective and safe.

The initiative, however, faces opposition from major pharmaceutical companies that fear a negative impact on innovation, while Kennedy argues the current distinctions in treatment stifle competition.