The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have announced a new partnership to accelerate access to biosimilar drugs, including new draft guidance for the scientific industry. The guidance outlines how the FDA should consider biologic drugs’ quality and efficacy, without hindering access for patients. The FDA will accept comments for 60 days once this guidance is published on the Federal Register. In the interim, the draft can be read here. 

At the livestreamed launch on Wednesday, Secretary Kennedy expressed his concern over what he views as unequal access to biosimilar medications. The FDA will release new draft guidance for companies developing biosimilars that the Trump Administration hopes will increase access to these drugs and reduce red tape for pharmacists. Catch the replay of the announcement, including Q&A with the scientific press, here.