Insulin glargine biosimilar gains South Korean approval

Biosimilars/News | Posted 16/03/2018 post-comment0 Post your comment

South Korea-based GC Pharma (formerly Green Cross Corporation) announced on 8 March 2018 that it had received approval for its insulin glargine biosimilar Glarzia from the Korean Ministry of Food and Drug Safety (MFDS).

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Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

The product is a proposed biosimilar to Sanofi’s Lantus (insulin glargine), which had worldwide net sales of US$5.7 billion in 2016. The patents on Lantus expired in 2014 in both Europe and the US [1].

The company plans to launch Glarzia Prefilled Pen, which was developed by Indian drugmaker Biocon, in the third quarter of 2018. Under a licensing deal made in 2016, GC Pharma holds exclusive sales marketing rights for Glarzia in Korea.

Glarzia will be the second insulin glargine biosimilar to hit the Korean market. Eli Lilly and Boehringer Ingelheim gained approval for their insulin glargine biosimilar from MFDS in November 2015, but only launched Basaglar in April 2017. The biosimilar is sold at a 14% discount of the originator drug and recorded sales of US$282,000 during 2017.

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1.  Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006

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Source: The Korea Herald

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