Merck drops Lantus biosimilar, blames pricing and production cost concerns

Merck & Co. has ended the commercialization of Lusduna, a version of Sanofi’s Lantus (insulin glargine), and will pay Samsung Bioepis a termination fee of around $155 million.

In 2014, Merck & Co. (known as MSD outside of North America) entered into an agreement with Korean biosimilar maker Samsung Bioepis to commercialize an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.

The product, Lusduna, formerly MK-1293, was approved in Europe in January 2017 as a biosimilar version of Sanofi’s Lantus, and six months later received tentative approval from the US Food and Drug Administration (FDA) as a follow-on biologic basal insulin in a pre-filled dosing device.

Merck & Co is paying Samsung Bioepis $155 million to end commercialization of insulin glargine product Lusduna. Image: iStock/pic_studio

But 15 months on, and Samsung Bioepis revealed in a note on the Korean stock exchange that its partner has terminated the deal and paid the firm a fee of approximately 176 billion Korean Won ($155 million).

“After a comprehensive assessment of the current and future market environment for insulin glargine, which included an assessment of anticipated pricing and cost of production, we made the business decision to terminate our agreement on the commercialization of the Lusduna pen and vial,” Merck told BioProcess Insider in an emailed statement.

“As a result of this decision, Merck will begin to reallocate resources including commercial and manufacturing capacity related to insulin glargine to other products.”

Samsung Bioepis – a joint venture between Samsung BioLogics and Biogen – did not comment on the termination when contacted by this publication. However, the insulin glargine product (project SB9) has been removed from the product pipeline on the company’s website.

Insulin glargine market

Competition and exclusions from commercial formularies at US insurers have seen sales of Lantus for French biopharma Sanofi, but the product still pulled in revenues of €4.6 billion ($5.3 billion) globally in 2017.

Eli Lilly and Boehringer Ingelheim were the first firms to receive US approval for its Lantus follow-on biologic in 2016. Basaglar – like Lusduna – was approved in the US through the 505(b)(2) pathway, and not the biosimilar 351(k) route.

Meanwhile, Mylan and Biocon received EU approval for their insulin glargine biosimilar Semglee earlier this year. The product was rejected by the FDA in June, but the firms are still looking to bring the product to the US.

Merck’s biosimilars

Despite the insulin glargine pull-out, Merck has said it remains committed to its biosimilar portfolio.

“We believe that biosimilars can present significant opportunities for cost savings through competition and improved patient access to therapies.

“This decision does not affect the other biosimilar assets currently in development with Samsung Bioepis. Both Merck and Samsung Bioepis remain committed to other biosimilar assets in oncology and immunology.”

Merck and Samsung Bioepis first entered into an agreement in 2013 to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates.