Regulation of Follow-on Biologics

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Abstract
Biopharmaceutical products, with U.S. sales in 2006 amounting to about $40.3 billion, are increasingly central to the treatment of major health problems affecting Americans.1 Since modern biopharmaceuticals date back to the 1980s, the first generation of such drugs has begun to lose patent protection (see table ). In other parts of the world, governments have crafted regulations defining the terms of competition from “imitator,” or generic, products. Many analysts have expressed concern that without new U.S. regulations, patent expirations may not be accompanied by the introduction of competing, lower-cost biologic agents — or that imitator products might be approved without sufficient proof of efficacy and safety, posing threats to public health. Although some biopharmaceutical products are nearly as simple as traditional small-molecule drugs, the vastly increased complexity of others means that it will be more difficult to ensure that an imitator product is biologically and functionally equivalent to the original. Because it may not be possible to create “true” generic versions of biopharmaceuticals, the term “follow-on biologic” is often used to refer to a new version of an existing biopharmaceutical that uses the same mechanism of action and treats the same clinical indications as the original.

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