There is a bit of buzz in DC around "biosimilars." Congress is currently debating legislation that would create a regulatory pathway for the FDA to approve biosimilars, also called "follow-on biologics."
As the name implies, biosimilars are similar to, but not the same as, an approved innovator biologic. This is because biologics derive from living organisms--as diverse as cell cultures, animals, fungi, and plants. Bill proponents claim that biosimilars could offer significant cost savings. Others believe the cost savings would be much less due to the substantial expense associated with producing and testing biological products.
Examples of biologics include vaccines, human insulin for diabetes, many hormonal therapies, and drugs for cancer, rheumatoid arthritis, multiple sclerosis, and other auto-immune diseases. About 630 biotech compounds are in development to treat more than 100 diseases, including 250 for various cancers.
As a healthcare company, we support legislation that would establish a regulatory pathway to approve biosimilar biologics as long as the bill (1) ensures patients' safety by requiring adequate clinical data; and (2) requires at least 14 years of data exclusivity to maintain incentives for innovation that will support the development of future medicines. A successful pathway will strike the right balance that both ensures patient safety and provides fair incentives for continued biopharmaceutical research.
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