Biosimilars

Merck KGaA in talks to sell its biosimilars R&D ops as shakeout looms

Merck KGaA CEO Stefan Oschmann

The biosimilars business is just getting established, but the shakeout among a group of high-powered rivals is already taking shape.

Merck KGaA CEO Stefan Oschmann told reporters this morning that the company is deep in talks to sell its biosimilars group, according to Reuters, dickering on a unit that has been targeting some familiar blockbusters like Humira (AbbVie), Rituxan (Roche) and Neulasta (Amgen).

Novartis Sandoz unit, Amgen and Merck/Samsung Bioepis have all mapped ambitious plans of their own to follow up the first wave of biosimilars in Europe with a new lineup of knockoffs for the US market. Amgen, for example, scored the first approval of a biosimilar of Humira, and the FDA has proven eager to back a full label on indications after a successful Phase IIII study in just one.

AbbVie, though, still relies on its flagship therapy for survival, and is vowing to wage a scorched earth legal campaign to keep control of their franchise for years to come.

That combination of major league players crowding in with competing copycats along with a degree of uncertainty in some cases on when a drug actually loses protection has conspired to get some companies, like Merck KGaA, to reassess their position and get out. Shire recently bowed out of a pair of biosimilar development deals, including one inherited in its Baxalta buyout. And a bigger shakeup will likely reduce the number of players even more.


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