[THE INVESTOR] Samsung Bioepis has received tentative approval from the US Food and Drug Administration to sell its biosimilar version of Sanofi’s blockbuster diabetes treatment Lantus, to be effective once it wins its on-going patent battle.

Lusduna Nexvue, developed by Merck and funded by the Korean firm, is an insulin glargine injection referencing Lantus which generated sales of US$6.6 billion, or a sixth of Sanofi’s total sales, in 2016.

 

Sanofi's Lantus

The firm has met all required regulatory standards for follow-on biologics for clinical safety, efficacy and quality, but is subject to an automatic stay for up to 30 months due to its legal battle with Sanofi.

“The patent case is expected to close soon with the FDA’s provisional approval,” KB Investment & Securities analyst Seo Keun-hee said.

Once launched, Lusduna Nexvue will become the Korean company’s second biosimilar product to hit the US market following Renflexis, copy version of J&J‘s Remicade, which received FDA approval in April.

It is also conducting late-stage clinical trials for an array of biosimilar candidates referencing global pharma firms’ top-selling drugs including Amgen’s Enbrel, AbbVie‘s Humira, and Roche’s Herceptin and Avastin.

Both Lantus and Lusduna Nexvue, administered via injection, are long-acting, man-made versions of human insulin.

Lusduna Nexvue was granted marketing approval in EU in January.

By Park Han-na (hnpark@heraldcorp.com)