Article | January 16, 2018

What's New in U.S. Biosimilar-Land?

By Leala Thomas

What’s New in U.S. Biosimilar-Land?

What exactly are biosimilars and why does this class of therapeutics have the potential to take over the biopharmaceutical market? Biosimilars are defined generally as large molecular-weight, complex molecules that are produced in living cells through genetic engineering. The U.S. FDA uses the following formal definition: A biological product that is highly similar to a United States licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. More simply, it is a biologic that is almost identical to a previously approved biological product, with no clinically meaningful differences in safety or efficacy.

Originator biologics have provided lifesaving treatment for cancer, inflammatory bowel disease, as well as several other diseases. However, the exorbitant cost of a biologic treatment regimen (up to $200,000 per year) is considered cost-prohibitive for many patients and a financial burden on insurance payers. In spite of these exorbitant costs, U.S. sales of biologics account for 50% of global sales value growth and their use continues to increase rapidly.

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