FDA Approves Teva-Celltrion Herceptin Biosimilar Herzuma

A biosimilar of Roche Holding blockbuster breast-cancer drug Herceptin has been approved for sale in the U.S., health regulators said Friday.

The medicine, Herzuma, is manufactured by South Korea’s Celltrion and would be sold in the U.S. by Teva Pharmaceuticals Inc. (TEVA, TEVA.TV).

The Food and Drug Administration has pushed for the development of biosimilars, which are lower-cost copies of complex and often expensive biotech drugs, as part of efforts to lower drug prices.

Roche’s Herceptin, also known by the generic name trastuzumab, gained FDA approval in 1998.

Herceptin accounted for more than $3 billion in sales for the first half of this year, up 2% from the comparable period a year earlier. Sales were helped during that period with 12% growth in the U.S., according to Roche’s financial documents.

In October, Swiss pharmaceuticals maker Roche said it expected less of an effect on U.S. sales from biosimilars than in Europe.

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