Statement of Richard Kingham

Summary of Statement of Richard Kingham

Before the Subcommittee on Health
of the House Committee on Energy and Commerce

May 2, 2007

Entire testimony available here. (PDF format)

Legislation creating a pathway for approval of similar biological products, or biosimilars, should ensure that those products are safe and effective and maintain adequate incentives for investment in research and development of new biotechnology medicines.

Because of the complexity of their active substances and the likelihood that they will differ from the innovative products to which they refer, biosimilars cannot be treated as generic drugs. Detailed requirements for approval should be developed in public proceedings, taking full advantage of the expertise of innovative manufacturers. Requirements will inevitably include comparative clinical tests, plus special premarketing and postmarketing tests for rare but serious side effects, such as immunogenicity. Biosimilars will not be interchangeable with reference products (or with each other) in the same manner as generic drugs. They should be labeled with distinct names to facilitate postmarketing safety surveillance and detection of rare adverse events.

Any pathway must also maintain incentives for costly and risky investments that are essential to bring new biotechnology-derived medicines to patients, including a substantial period of nonpatent data exclusivity. Legislation should not alter existing rules under patent law that protect innovative products, or make changes that favor biosimilars over innovative products.

The European Union system for regulation of biosimilars, which is summarized in the full statement, provides an instructive example. It includes procedures to ensure that biosimilars are rigorously tested for safety and effectiveness, as well as special measures to detect rare but serious side effects. It also provides a substantial period of data exclusivity, while maintaining key principles of patent law that protect innovative products.