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Biotech Stocks Facing FDA Decision In March

Pfizer
Pfizer

The FDA is slated to announce its decision on whether it would approve Pfizer Inc.’s (PFE) PF-05280014, a proposed biosimilar to Herceptin, this quarter (Q1, 2019).

Herceptin, developed by Roche’s Genentech, is indicated to treat certain HER2-positive breast cancers. The drug generated global sales of 6.98 billion Swiss francs for Roche in 2018.

PF-05280014 was turned down by the FDA last April, with the Company being asked to furnish “additional technical information.”

If approved this time, PF-05280014 will be fourth Herceptin biosimilar to be greenlighted by the FDA.

In Europe, Pfizer’s biosimilar version of Herceptin is approved under the trade name TRAZIMERA and has been marketed there since June 2018.

PFE closed Tuesday’s trading at $43.02, down 0.14%.