Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010, the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
In contrast to most drugs that are chemically synthesized and have structures that are known, biologics are complex compounds made from living cells and have highly complex structures that are not easily understood, characterized or replicated. That is why the copies are called biosimilar and not generic. Biosimilars are "similar to" but not exact copies of biologics and small differences can have unexpected or harmful clinical outcomes for patients. While the ultimate goal is to find a balance between producing economical drugs and respecting the drug-discovery process, patient safety should be paramount.
It is critical that a science-based approach be used to put in effect the biosimilars pathway, but the United States need not reinvent the wheel. The European Union began to establish the first formal regulatory pathway for biosimilars in 2003, and that process can serve as a baseline model for the U.S. to improve on. By pioneering in this regulatory area for the last 8 years, the E.U. has gathered much data which can, at a minimum, help inform our own policy makers. We should take advantage of the opportunity to learn from their experiences, both positive and negative.
Pharmacovigilance is the surveillance of a drug's performance, particularly of adverse reactions, after it has been released for marketing. Because biosimilars could be approved on less data than other medicines, pharmacovigilance is extra important. Before biosimilars are introduced into the U.S. market, a robust traceability system (including distinctive labels, product tracking codes, and a way to report adverse events) must be in place to ensure accurate surveillance.
Doctors and patients should be able to carefully choose the best course of treatment rather than have legislators and regulators decide for them. The path the government decides to pursue in approving biosimilars should reinforce this principle.