Here's some welcome news for diabetics dealing with the high price of insulin: The Food and Drug Administration has approved Mylan (MYL) and Biocon's Semglee, which is essentially identical to Sanofi's (SNY 5.90%) insulin product Lantus.
The companies didn't disclose what they plan to charge for Semglee when announcing the approval, but Mylan CEO Heather Bresch implied that it would be cheaper than Lantus. "This approval is an important milestone, first and foremost for the millions of patients living with diabetes in the U.S. as we seek to expand their access to insulin through more affordable treatment options."
The opportunity for Mylan and Biocon (which bills itself as India's largest biopharmaceutical) is substantial; IQVIA estimates that Sanofi took in $1.68 billion in revenue from Lantus vials and $4.33 billion from the Lantus SoloSTAR Pen in the 12-month period that ended in April.
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Rather than having Semglee approved as a generic drug or a biosimilar, the companies used the 505(b)(2) pathway, which allows drugmakers to get equivalent drugs approved using the safety data from the original approval. That path is often used when the route of administration is being changed -- from oral to injection, for instance -- but both Semglee and Lantus are injected and available in a vial or in a pre-filled pen.
The companies ran two clinical trials, Instride 1 and Instride 2, which demonstrated there was no difference in safety, efficacy, and immunogenicity between Semglee and Lantus in patients with type 1 and type 2 diabetes. Mylan will sell the drug in the U.S., as well as Canada, Australia, New Zealand, the EU, and European Free Trade Association countries, while Biocon has exclusive rights for Japan and a few emerging markets. Elsewhere, the companies will share commercialization rights for the drug, which has been approved in more than 45 countries.
