Presidential candidate Barack Obama recently announced a plan to give $6 billion a year in tax credits to small businesses to encourage them to provide health insurance to employees. According to Reuters, Obama would pay for this by “making so-called ‘biologic’ drugs easier to bring to market in generic form.”
Unfortunately, this is easier said than done. There are serious safety issues that must be addressed before allowing the introduction of these “follow-on” biologics onto the market and into patients.
Traditional generic forms of pills can literally be made identical to the originator forms because of their small size. Hence, generics can rely on the safety studies done by the originator companies, and the FDA appropriately allows them an abbreviated approval process.
But biologics, such as injectable drugs, are much more complicated than these “small molecule” pills. Aspirin, for example, has just 21 atoms, while Herceptin, a popular cancer biologic, contains about 25,000.
Biologics are proteins made by life forms such as cells and bacteria. These life forms exhibit diversity in metabolism and composition, making the final product a heterogeneous mix that simply cannot be copied exactly. It also makes them very complex to produce compared with conventional drugs.
So “follow-on” forms can only be similar to the original, not identical. That’s why they’re called “follow-ons” ” there’s no such thing as a “generic” biologic drug. Europe has recognized this too, and call them “biosimilars.”
All this complexity makes replicating them a more dangerous affair. Follow-ons can induce severe, unanticipated immune reactions in patients.
In 2000, for instance, a fully-tested biologic created in the United States and cooperatively licensed in Europe induced patients to experience “pure red-cell aplasia,” where their bodies could not make red blood cells. Some died, and many were permanently injured. Even today, after eight years of research, the cause of these reactions is unknown.
Yet policymakers in their efforts to speed cheaper drugs to consumers are considering policies that would effectively treat biologics like small molecule pills. Sen. Obama believes such rapid approvals of follow-ons could be a funding mechanism for his tax-credit plan.
But he ” and other politicians supporting such measures ” must proceed cautiously because of the patient safety issues. We cannot allow the limited testing of conventional generic drugs as a model for biologic drugs.
Policymakers should heed the lessons from Europe’s pure red-cell aplasia experience as they weigh options for a regulatory system here in America.
Currently, the EU mandates clinical trials and data for all follow-on forms to ensure safety. It also requires follow-on companies to track and collect information on potential adverse reactions. This helps ensure that negative past experiences are avoided and that any allergic reactions are detected early.
We should adopt a similarly rigorous system, recognizing the challenges of biologic drugs. As for all new drug forms, patient safety must be the primary focus.
Sen. Obama rightly recognizes the importance of biologics. And it’s a noble goal to increase patient access to these drugs. But follow-on biologics policy should not be politicized by tying it to funding for an unrelated tax credit.
Policymakers must understand the science and risks ” and the ultimate costs if hastily introduced ” of follow-ons as they attempt to move biologics policy forward.
” Bryan A. Liang, M.D., Ph.D., J.D., is executive director of the Institute of Health Law Studies, California Western School of Law, and co-director of the San Diego Center for Patient Safety, University of California, San Diego School of Medicine.