Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics, which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer.

The evolution of the European Union"s approach to regulating biosimilars is a potential model upon which we can design a process that facilitates access to biosimilars while providing assurances of safety.

As Congress considers legislation that would allow imitative biological products, known as "biosimilars," to rely on the safety and efficacy data of original innovators, it must ensure that any provisions passed will foster, not stifle, discovery.

Drug prices have recently become less expensive with the spread of generic versions, but Medicaid support seems to make drugs more expensive.

Congress should act in protecting patents for follow-on biologics, relying on a few basic principles that do not suppress research and developmentin this vital sector.

Follow-on biologics are not like ordinary generics, and therefore require Congress to exercise a deft regulatory hand.