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.
A recent report indicated that the FDA and the European Medicines Agency (EMA) have agreed to harmonize their review path, which may help the FDA to catch up with its overseas counterpart. While the EMA is ahead of the FDA, it continues to learn from the process and challenges remain for both regulatory agencies. Any approach must be science-based and uphold patient safety.
Patient safety is paramount because these biologics are not your typical medicines. Biologics are created from cutting-edge medical technology and have shown great promise in treating cancer, diabetes, Parkinson’s disease, Multiple Sclerosis and many other serious and chronic conditions. Most biologics are administered through a vein at the doctor’s office, hospital or clinic and do not come in pill form. They are not made from chemical building blocks; rather they are intricate, multi-dimensional compounds grown from living cells.
Because of their unique structure, replicating biologics is difficult. Unlike the common generic drugs with which we are familiar, biologic copies, called biosimilars, cannot be exactly the same as the original and, if not carefully scrutinized, may produce unexpected side effects or outcomes in patients.
Even the smallest detail in the biosimilar production process can be critical. As these medicines have a very large molecular size, small changes can easily trigger autoimmune responses in the body. Altering one atom in a 20,000 thousand atom molecule can have an unpredictable effect on the body.
Due to complexity, there are no shortcuts to biosimilars. They must be subjected to the same rigorous testing and standards as the original drugs.
As the FDA creates a pathway for biosimilar development and manufacture, certain steps must be included. They must require appropriate clinical trials and testing. Each medicine must have a unique name to help accurately trace its performance and effects. And product labels must be completely transparent and reflect trial outcomes of that specific biosimilar product, not the original.
Above all, mechanisms must be put in place that give patients and their physicians the power to choose the course of treatment that best meets the unique demands of each individual case. As our government moves forward in implementing a pathway to replicate biologics, it’s important that doctors, patients and regulators have the facts they need. Biologics and biosimilars are the future of medicines and hold great promise for millions of Americans suffering from chronic conditions. But at the end of the day, the single most important priority of all medical treatments is, and must remain, the patient.
Kara Nett Hinkley is public policy coordinator for the Colorado Chronic Care Collaborative.
