PREVIEW

FDA Moves To Speed Up Approval Of Generic Biologic Drugs To Cut Health Costs. The US Food and Drug Administration is set to streamline how generic versions of complex biological drugs, known as biosimilars are approved, in a move aimed at lowering healthcare costs and boosting competition. Biologic drugs, made from living organisms like bacteria and animal cells, are harder and more expensive to produce than traditional chemical medications. Until now, their generic counterparts have faced a longer, more complex approval process. The FDA’s new draft guidance, announced Wednesday, proposes reducing the number of studies and clinical trials required to show that a biosimilar is equivalent to an existing approved product. FDA Commissioner Dr. Marty Makary said the reforms could “significantly lower health care costs in America” by making advanced treatments for cancer, autoimmune diseases and rare disorders more affordable. The move is expected to accelerate access to lifesaving therapies while easing the financial burden on millions of patients.
Instructions: THIS VIDEO MUST NOT BE EDITED FOR LENGTH TO COMBINE WITH OTHER CONTENT