FDA Struggles To Foster An Affordable Biosimilar Insulin

Law360 (October 23, 2019, 3:43 PM EDT) -- There is widespread medical need for insulin products — insulin is listed on the World Health Organization's model list of essential medicines — but there is little market competition. Eli Lilly and Co., Novo Nordisk A/S and Sanofi-Aventis control 90% of the global insulin market.

The absence of competition has led to incredible price inflation for insulin products. Insulin list prices increased nearly 600% from 2001 to 2015, according to the Congressional Research Service; average list prices for four classes of insulin products had increased 15% to 17% per year from 2012 to 2016, reported the Leonard D. Schaeffer Center for Health...

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