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NEW DELHI: Biocon Biologics India Ltd and its partner Mylan N.V. on Monday launched their insulin glargine injection under the brand Semglee in the US in vial and pre-filled pen presentations.

Mylan, which is responsible for commercialisation in the US, would offer Semglee at a wholesale cost of $147.98 per package of five 3ml pens and $98.65 per 10ml vial, making it the cheapest brand of insulin glargine in the US market, the Biocon subsidiary said in a statement.

“While providing our product at the most competitive list price on the market is an important step towards ensuring that those who need insulin are able to access and afford it, we also know that there is still work to be done to ensure this access and affordability reaches patients at the pharmacy counter,” Mylan chief executive officer Heather Bresch said as per the statement.

Insulin glargine is approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. The drug has an identical amino acid sequence to Sanofi’s Lantus, the company said.

“The commercialization of our insulin glargine in the US represents another milestone achievement for Biocon in making insulin-based therapy increasingly accessible for people with diabetes globally… The US launch of Semglee takes us closer to realizing our aspiration of reaching ‘one in five’ insulin dependent people with diabetes worldwide” Biocon executive chairperson Kiran Mazumdar-Shaw said.

Sanofi’s total sales for the 12 months ending June were approximately $1.64 billion for Lantus vial and approximately $4.36 billion for Lantus SoloSTAR Pen, Biocon Biologics said quoting market research firm IQVIA’s data.

Biocon had received an approval from the US Food and Drug Administration for the biosimilar in June.

The US FDA approval and the launch follow a favourable ruling from the US Patent and Trademark Appeal Board (PTAB) in its dispute with Sanofi over four patents of their insulin injection pen.

In October 2017, Sanofi had initiated a patent infringement litigation against Biocon and Mylan’s application for Semglee in the New Jersey court that included the formulation patents as well as injection pen for it. This triggered a 30-month stay on the product’s approval.

The PTAB, however, earlier this year found Sanofi’s claims unpatentable.

Mylan expect Sanofi to seek certain appeals of those judgments, but is confident it will not affect commercialization, Biocon said.

Mylan and Biocon Biologics are exclusive partners on 11 biologics for the global markets, which cover biosimilar and insulin products, including insulin glargine.

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