Current Regulatory and Legal Considerations for Follow-On Biologics

As patents for the first generation of biotechnology-derived medicines expire, regulators must develop standards for follow-ons. Requirements for traditional generic drugs will often be insufficient because follow-on biotechnology medicines will not be identical to reference products. Policymakers must also consider what products to include, how to set data requirements, whether to permit interchange of follow-ons and reference products, what postmarket requirements to impose, and how to balance cost savings from follow-ons against incentives for innovation.