FDA issues draft guidance on biosimilar product

The U.S. Food and Drug Administration (FDA) on Thursday issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States."These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in a statement.Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials.A biosimilar is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency.The Patient Protection and Affordable Care Act, signed into law by U.S. President Obama in 2010, amended the Public Health Service Act to create an abbreviated approval pathway for biological products. Through this new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product.The FDA is seeking public comment on these draft guidance documents. In finalizing the guidance documents, the agency will consider the information received from the public.