Merck KGaA Seeks to Exit the Biosimilar Business

Stanton R. Mehr

As a result of increasing competition, a smaller player (in the biosimilar field) is seeking to sell its nascent biosimilar business.

As a result of increasing competition, a smaller player (in the biosimilar field) is seeking to sell its nascent biosimilar business. Merck KGaA (which operates in the US as EMD Serono and is not associated with Merck & Company) has engaged the services of the investment banker JP Morgan Chase to seek potential buyers for its biosimilar unit.

Merck KGaA has decided to fortify its pipeline efforts instead on multiple sclerosis, where it has a strong marketing position with its product Rebif®, and in several cancer therapeutic approaches. The company’s only late-stage biosimilar is adalimumab (MSB11022), which is currently involved in a phase 3 trial with 400 patients that is supposed to be completed by September 2017. The primary endpoint results are slated to be available, however, in December 2016.

According to the announcement, the company’s biosimilars business could be valued at as much as $1 billion, not only based on its adalimumab agent but several undisclosed early-stage biosimilars. However, Merck may not make a big splash with its key product, as Amgen’s adalimumab has already been approved, and it may be one of several biosimilar versions to hit the market in the next few years, pending clearance of patent litigation.

In other news…Active biosimilar player Celltrion, from South Korea, has announced its submission of an application to the European Medicines Agency to license its version of Herceptin®. Interestingly, although it is approved for use in South Korea under the brand name Herzuma®, this biosimilar only commenced phase 1 trials in the US in September for eventual application to the Food and Drug Administration. No timetable has been announced for US submission.