Samsung Bioepis biosimilar to Roche Herceptin wins FDA nod

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.

U.S: 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 sold by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and is developed by Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc.

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

#FDAapproves Ontruzant (trastuzumab-dttb), biosimilar to Herceptin (trastuzumab): https://t.co/9xFcZdCOZ4. View PI @: https://t.co/guLOKbXIpX. pic.twitter.com/HoRU13ahfc

— FDA Drug Information (@FDA_Drug_Info) January 18, 2019

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.

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