FDA guidance aims to spur biosimilar availability: The guidance addresses Interchangeability-the ability to substitute biosimilars for biologics by pharmacists

In a long-awaited move, the US Food and Drug Administration has released a set of guidelines intended to stoke the market for biosimilars, generic versions of complex biological drugs, frequently proteins, that are used to treat diseases like cancer and autoimmunity. The FDA has already approved 19 biosimilars. However, none of those drugs can be substituted for the reference biological drug from which they are derived. The new guidelines set testing standards for a biosimilar to be declared interchangeable, allowing pharmacists to replace a branded drug with a generic biologic in the same way they currently do for small-molecule drugs, without having to talk with a doctor first. Both patient advocates and the FDA hope that bringing more biosimilars to market will improve access to these groundbreaking drugs by giving consumers more choices and by lowering prices. In one study of patient costs for biologics to treat autoimmune disorders, annual. © 2019 Chemical & Engineering News.