Samsung Bioepis-Merck biosimilar to Roche's Herceptin wins FDA nod

(Reuters) - The U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AG's blockbuster breast cancer treatment, Herceptin.

The biosimilar, Ontruzant, is co-developed by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc.

The approval comes just a few weeks after the health regulator gave Celltrion Inc's Herzuma - another biosimilar to Herceptin - its nod to market it commercially.

Herceptin, which generated sales of 7.01 billion Swiss francs in 2017, is one of the world's most successful antibody drugs and has been a mainstay of Roche profits for many years.

Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.

The FDA had declined to approve Pfizer's biosimilar of Herceptin in April.

(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Maju Samuel)

01/18/2019 15:41

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