Worldwide experience with biosimilar development

TLDR

High‑cost biologics limit access worldwide, prompting the development of biosimilars—follow‑on biologics that meet stringent similarity standards to originators—under regulatory frameworks pioneered by the FDA and EMA as patents on complex biologics, especially monoclonal antibodies, expire. The Biologics Price Competition and Innovation Act authorizes FDA approval of biosimilars and grants the agency authority to designate interchangeability with reference products. Use of biosimilars has already lowered treatment costs globally, and FDA approvals are expected to further enhance patient access to high‑quality biologics and enable the adoption of innovative molecules from the biopharmaceutical pipeline.

Abstract

Limited access for high-quality biologics due to cost of treatment constitutes an unmet medical need in the United States (US) and other regions of the world. The term "biosimilar" is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications. Use of biosimilar products has already decreased the cost of treatment in many regions of the world, and now a regulatory pathway for approval of these products has been established in the US. The Food and Drug Administration (FDA) led the world with the regulatory concept of comparability, and the European Medicines Agency (EMA) was the first to apply this to biosimilars. Patents on the more complex biologics, especially monoclonal antibodies, are now beginning to expire and biosimilar versions of these important medicines are in development. The new Biologics Price Competition and Innovation Act allows the FDA to approve biosimilars, but it also allows the FDA to lead on the formal designation of interchangeability of biosimilars with their reference products. The FDA's approval of biosimilars is critical to facilitating patient access to high-quality biologic medicines, and will allow society to afford the truly innovative molecules currently in the global biopharmaceutical industry's pipeline.