Merck Terminates Follow-on Insulin Agreement with Samsung Bioepis

According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.

Despite tentative FDA approval received in July 2017, Merck and Samsung have faced significant challenges in bringing the follow-on biologic, Lusduna Nexvue, to market in the United States.

One hurdle, patent infringement litigation brought by reference product developer Sanofi, was ongoing, and triggered an automatic stay on the FDA’s final approval of up to 30 months.

Merck concluded to end the partnership after assessing the current and future market for the product, including pricing and the product’s cost, before reaching its decision. In ending the partnership, Merck paid Samsung $155 million to cover investments made thus far in the product, plus interest, reported FiercePharma. However, its partnership with Samsung on other biosimilars in oncology and immunology remain unchanged.

Drug developer Mylan, in a partnership with Biocon, is having similar troubles with its follow-on insulin referenced on Lantus. The product, which is already approved in Europe and sold under the name Semglee, is currently undergoing its own patent lawsuit from Sanofi. In the 70-page lawsuit filed in October 2017, Sanofi alleged that Mylan is infringing on 18 patents and asked a federal court in New Jersey to intervene in the launch efforts.

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

Competing against reference Lantus in the follow-on insulin market already is Boehringer Ingelheim’s Basaglar, the first follow-on insulin glargine to earn FDA approval.