Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing approval from both the European Commission (which applies to all 28 European Union member states) and the European Economic Area member states of Norway, Iceland, and Liechtenstein.[1] Additionally, the Therapeutic Goods Administration approved the biosimilar for use in Australia. While the pharmaceutical partners received U.S. approval for their breast cancer drug Ogivri (the biosimilar Trastuzumab) in December 2017, this is their first co-developed biosimilar to be approved in Europe.[2]

Insulin glargine is a biosimilar of Sanofi’s Lantus™, in which the amino acid sequence of natural human insulin has been genetically modified to improve its absorption, distribution, metabolism, and excretion characteristics in patients with either type 1 or type 2 diabetes.[3] This insulin analog thus provides a drug that is more readily and quickly accepted by the body, with a prolonged duration of activity such that patients may control their blood sugar with just a single dose per day. The approval in Europe and Australia is for a 100 unit/mL 3 mL prefilled disposable pen of the insulin glargine, for application by subcutaneous injection.

While Semglee™ is the third insulin glargine biosimilar to hit the European market (behind Eli Lilly’s Abasaglar™ and Merck’s Lusduna™) and second in Australia (again behind Eli Lilly’s Abasaglar™), the manufacturers hope that the drug will provide an affordable and high quality option for patients and expand the diabetes market on a global scale. The number of people with diabetes in Europe is expected to reach 38 million over the next ten to twelve years and there are nearly 2 million people, and counting, currently living with diabetes in Australia.[4] Thus, as the diabetes pandemic continues to grow at an alarming rate, Mylan and Biocon are entering the lucrative $6 billion global market at the perfect time.[5] The duo plans to launch the product in both Europe and Australia by the end of 2018.

In the same week that Mylan and Biocon announced their success with their insulin glargine biosimilar abroad, the U.S. Food and Drug Administration approved Sanofi’s 900-unit, or 300 unit/mL 3mL, insulin glargine pen, the highest capacity long-acting insulin pen currently on the U.S. market.[6] Sanofi hopes that the new disposable prefilled pen (named Toujeo Max SoloStar), which includes double the dosage of its original SoloStar pen, will ultimately reduce the number of injections needed for some adults with diabetes. With its higher capacity, the pharmaceutical company also expects that the Max SoloStar pen will allow for fewer refills and related copays, depending on the individual’s insurance coverage.[7]

[1] Mylan, Biocon Get Approval for Glargine Insulin in Europe, Australia, RTTNews (March 28, 2018), available at http://www.rttnews.com/2876753/mylan-biocon-get-approval-for-glargine-insulin-in-europe-australia.aspx (last accessed April 2, 2018).

[2] Id.

[3] Ambika Basa, Efforts to Develop Generic Versions of Insulin Glargine an Exciting Evolutionary Trend in Diabetes Treatment (March 28, 2018), available at http://www.editiontruth.com/efforts-develop-generic-versions-insulin-glargine-exciting-evolutionary-trend-diabetes-treatment/ (last accessed April 2, 2018).

[4] Viswanath Pilla, We expect roll out of insulin glargine in Europe to start in second half of 2018, says Biocon (March 29, 2018), available at https://www.moneycontrol.com/news/business/companies/we-expect-roll-out-of-insulin-glargine-in-europe-in-second-half-of-2018-says-biocon-2539125.html (last accessed April 2, 2018).

[5] Id.

[6] See Labeling-Package Insert for NDA 206538, Toujeo SoloStar Insulin Glargine Recombinant, available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206538 (last accessed April 2, 2018).

[7] FDA Approves High-Capacity Insulin Glargine Pen, Healio Endocrinology (March 27, 2018), available at https://www.healio.com/endocrinology/diabetes/news/online/%7Bcec71f19-7d1e-4b27-b4b9-dd7df673ff74%7D/fda-approves-high-capacity-insulin-glargine-pen (last accessed April 2, 2018).