We expect roll out of insulin glargine in Europe to start in second half of 2018, says Biocon

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Biocon on Friday said it expects its partner Mylan to launch insulin glargine across various markets in Europe in the second half of 2018. The company didn't specify the Australian launch but said it will happen later this year.

Biocon and its partner Mylan on Thursday said they have received approval for insulin glargine in Europe and Australia. After Japan, Europe and Australia were two highly regulated markets that the company has approval to sell the long acting insulin - the biosimilar version of French drug maker Sanofi's Lantus.

Below is an edited excerpt from email interview with Siddharth Mittal, President - Finance of Biocon.

The approval of Mylan and Biocon’s biosimilar Insulin Glargine, Semglee, by the European Commission is significant as it is the first biosimilar approval in EU from our joint portfolio. It comes close on the heels of Ogivri, our biosimilar Trastuzumab, being the first biosimilar from Mylan and Biocon’s joint portfolio to be approved in the US.

It is also a key validation of our development, regulatory and manufacturing capabilities of Biocon, which has emerged as a credible, global insulins player committed to address the growing healthcare challenges associated with diabetes.

The EC approval furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. The global market opportunity for insulin glargine is over USD 6 billion.

Mylan expects to begin launching the product across various markets in Europe in the second half of 2018.  The EC approval of Semglee applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Semglee is one of the three insulin analogs being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.

Diabetes is a growing pandemic and going ahead there will be an incremental demand for both basal and other forms of insulin as it is largely an underserved market. In Europe, the number of people with diabetes are expected to grow to 38 million by 2030.

Even though Biocon-Mylan will be the third player in the biosimilars Insulin Glargine market in Europe, we are also confident of being able to expand the diabetes market in a significant way.

We cannot comment on a competitor’s market share or success but biosimilars have generally been well accepted in the EU thus far.

Eli Lilly’s Biosimilar Glargine became the first Biosimilar Glargine to be registered in Australia, but the product is as yet unavailable in the market. Semglee is the first biosimilar approval from Biocon and Mylan’s joint portfolio as well as the first biosimilars from India to approved in the country. Mylan plans to launch Semglee in Australia later this year.

Mylan and Biocon’s Semglee will offer a high quality, more affordable biosimilar insulin glargine to the nearly 2 million people are currently living with diabetes in Australia. We hope to bring down the total annual cost burden of diabetes in Australia  which is currently estimated at $14.6 billion.

Marketing applications for Semglee have been submitted in Canada and the US Several submissions are planned for key Emerging Markets.