Posted from: Monday, December 28, 2015 - 10:07 AM - Present

Basaglar Approved

December 17, 2015 – The U.S. Food and Drug Administration (FDA) approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in patients with diabetes. Basaglar is manufactured by Lilly and Boehringer Ingelheim. Although it is a new branded insulin, it has the same amino acid sequence as Sanofi’s Lantus (insulin glargine), a product which had approximately $8 billion in worldwide sales in 2014. Following terms within a settlement agreement, Basaglar will launch in December 2016. It will be available as a 100 units/mL (3mL) KwikPen delivery device. Mylan and Merck/Samsung Bioepsis are both developing insulins biosimilar to Lantus. Both could submit applications to market their products by the end of 2015 or early 2016. However, ongoing litigation over additional patents on Lantus is expected to delay availability until 2017 or 2018.

 

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Last Updated Sunday, June 18, 2017 - 08:14 PM.