By Kara Nett Hinckley, Public Policy Coordinator, Colorado Chronic Care Collaborative
Denver Post
How many of us have watched a loved one or friend suffer from a serious illness and wished for a miracle treatment that could help them with their struggle? Biologic drugs are not miracles, but they are a new, often better way of treating many life threatening conditions and chronic diseases. As the Food and Drug Administration outlines the regulatory pathway to replicate biologics – a process that is distinct from creating generic pharmaceuticals – we must ensure proper measures are in place to uphold their safety and effectiveness.
Chronic disease is one of the most challenging and costly healthcare issues in America. In Colorado, one in four – some 1.2 million citizens – live with a chronic disease like diabetes or Multiple Sclerosis.
The 2010 Affordable Care Act instructed the FDA to outline an approval process for replicated biologics, called biosimilars, following Europe who has worked on a similar framework since 2004.
