The US Food and Drug Administration (FDA) today issued three draft guidance documents on biosimilar product development to assist industry in developing these products in the United States. The Patient Protection and Affordable Care Act, signed into law by President Obama las year, amended the Public Health Service Act to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials, but can include a wide variety of vaccines, blood and blood components, gene therapies, tissues, and proteins. The FDA is seeking public comment on the three draft guidance documents.