Mylan, Biocon Launch Insulin Glargine Biosimilar in the United Kingdom

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

Semglee is approved in the European Union as a once-daily 100 units/mL dose, long-acting basal insulin indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged 2 years old and above.

“Insulin glargine biosimilars play a key role in the challenges faced by the [National Health Service, NHS] and offer a better value option by being able to deliver increased affordability compared with the originator insulin glargine while still offering comparable safety, efficacy, and tolerability,” said Jean-Yves Brault, Mylan’s UK country manager.

Nearly 1 in 17 people living in the UK are believed to have diabetes, and the NHS currently spends around 10% of its entire budget on managing the disease, highlighting the need for lower-cost options.

“The UK launch of Semglee, a biosimilar insulin glargine co-developed by Mylan and Biocon, is a reflection of our long-standing commitment to increasing insulin access for diabetes patients through the development of high quality biosimilars,” commented Paul Thomas, chief commercial officer at Biocon.

However, though approved in the European Union, the follow-on insulin glargine has yet to reach approval in the United States, where it is the subject of ongoing patent infringement litigation. Sanofi, maker of reference insulin glargine Lantus, filed suit against Mylan in October 2017 alleging that Mylan infringed upon 18 patents and asked a federal court in New Jersey to intervene in any launch efforts.

The lawsuit has not been the only challenge to bringing the follow-on insulin to the US market, as it received a Complete Response Letter (CRL) from the FDA in June 2018, citing production problems at the Malaysia plant responsible for producing the product.

Mylan and Biocon have partnered on the development and marketing of various biosimilar and insulin products. Mylan owns the exclusive commercialization rights for the insulin glargine follow-on/biosimilar in the United States, Canada, Australia, New Zealand, the European Union, and European Free Trade Association countries. Conversely, Biocon has exclusive commercialization rights for Japan and a few other emerging markets, as well as co-exclusive commercialization rights jointly with Mylan in the rest of the world.