DHHS, Office of the Assistant Secretary for Planning and Evaluation (ASPE)

Lewin contact: Clifford Goodman

Unlike most conventional drugs, biological products are usually large, complex molecules that are produced by living organisms. These commercially engineered biologics currently account for billions of dollars in health care spending. Starting early last century, Congress has regulated most biologics separately from small molecules under the Biologics Control Act, which was later incorporated into the Public Health Service (PHS) Act. Although some biologics are regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) for historical reasons, and are, therefore, candidates for generic production through section 505(j), an Abbreviated New Drug Application (ANDA), or through 505(b)(2), using data from previously approved innovator biologics to make claims of safety and effectiveness, there is no abbreviated path for replica or closely similar follow-on products for biologics under the PHS Act. While this group of products is known by various names, this report uses the term “follow-on protein products” (FoPPs).

Due to the potential cost savings that FoPPs could provide in the US market, members of Congress have made various proposals for establishing a regulatory pathway for FoPPs. The purpose of this report is to provide an unbiased estimate of potential cost savings from the introduction of FoPPs under multiple scenarios for abbreviated regulatory pathways. Findings from this analysis may be useful in the context of ongoing policy deliberations. A better understanding of the potential impact of legislative provisions for the regulatory pathway on cost savings may inform policymakers as such a pathway is considered.

"Throughout the engagement, Lewin consultants listened to us and delivered superb analyses and thoughtful guidance–not canned solutions."  NONPROFIT HEALTH SYSTEM