Mylan and Biocon Biologics launch Lantus biosimilar in the US
Semglee available in vial and pen presentations at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market.
Mylan and Biocon Biologics India have announced the US launch of Semglee (insulin glargine injection) in vial and pre-filled pen presentations, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
Dr Thomas Blevins, lead investigator for the INSTRIDE clinical trials, said that Semglee yielded similar glycemic results compared with the reference insulin glargine (Sanofi's Lantus) in participants with type 1 and 2 diabetes. The safety, including immunogenicity, was also similar.
As a result, this insulin was approved by the FDA for the same indications as its reference product, thus expanding access for millions of people.
To encourage broad patient access to this important medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC)1 of $147.98 per package of five 3 mL pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market.
Mylan President Rajiv Malik said bringing to market both the vial and pen presentations of Semglee is "the first for any company following the reference product".
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