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article imageU.S. approves first biosimilar medicinal product

By Tim Sandle     Mar 14, 2015 in Business
The U.S. Food and Drug Administration (FDA) has approved pharma company Sandoz’s drug Zarxio. This is a biosimilar to Amgen’s filgrastim, which is mainly prescribed for cancer patients.
Biosimiars could well become the major business issue in the pharmaceuticals market over the coming decade. Biosimilars (also known as follow-on biologics) are medical products that are a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original products. They can be manufactured when the original product's patent expires and, in theory, offered to the consumer at a lower price. This is a little like the process with generic drugs; however, biological products have not been part of this process due to their complexity.
In the U.S., the move towards biologics was made possible when President Obama signed the Patient Protection and Affordable Care Act (Affordable Care Act) in 2010.
Now the first U.S. biosimilar has been approved. The FDA has green lighted Zarxio, a biosimilar produced by Novartis subsidiary Sandoz that is similar to Amgen’s Neupogen (filgrastim). Like filgrastim, Zarxio is intended for use by patients undergoing chemotherapy, as well as patients with severe chronic neutropenia—low neutrophil count—among other conditions.
The FDA approval is significant as it paves the way for other pharmaceutical manufacturers to produce lower-cost versions of established biological medicines on a larger scale. To this effect, Leah Christl, FDA’s associate director for therapeutic biologics, said in a statement: "Biosimilars are likely to create greater competition in the medical marketplace."
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