Datapoint: FDA Rejects Biocon’s NovoLog Biosimilar

January 23

The FDA recently rejected Biocon Biologics’ latest biosimilar insulin product, a copy of Novo Nordisk’s NovoLog, citing a need for additional data and pending improvements at the company’s manufacturing facilities. Biocon is the manufacturer of Semglee, a biosimilar for Sanofi’s insulin Lantus. As a short-acting mealtime insulin for the treatment of type 2 diabetes, NovoLog currently holds covered or better status for 74% of all insured lives. 52.5% of lives have preferred, unrestricted access to NovoLog.

SOURCE: MMIT Analytics, as of 1/18/23