FDA approves biosimilar to breast cancer blockbuster

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The US Food and Drug Administration has announced that it has approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment, Herceptin.

Reuters Health reports that the biosimilar, Ontruzant, is sold by Merck Sharp & Dohme Corporation, a unit of Merck & Co, and is developed by Samsung Bioepis, which is a joint venture between Samsung BioLogics and Biogen Inc.

The report says 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 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 report says the FDA had declined to approve Pfizer’s biosimilar of Herceptin in April.

Reuters Health report

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