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Pfizer's Herceptin Biosimilar Moving Forward Amid Rising Competition

 
• By Sten Stovall

Pfizer hopes positive top-line Phase III trial data on its Herceptin (trastuzumab) biosimilar can help it tap the lucrative market in HER2-overexpressing cancers, but analysts say that therapeutic space looks increasingly crowded with no clear favorite yet in sight.

Pfizer Inc. Dec. 1 said it was "encouraged" by good top-line results from its Phase III pivotal comparative REFLECTIONS B3271002 study of its PF-05280014 biosimilar for treating patients with HER2-positive metastatic breast cancer. The 690-patient study met its primary endpoint and was designed to measure the safety and efficacy of the biologic follow-on versus Genentech Inc.'s Herceptin (trastuzumab).

Pfizer, which is seeking new sources of revenue growth, said the Phase III trial showed equivalence in the primary end point versus trastuzumab taken in combination with paclitaxel. That primary endpoint was objective response rate (ORR) by week 25 of study treatment

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