According to Pfizer, the US Food and Drug Administration’s (FDA) rejection of the biologics license application (BLA) for PF-05280014 (trastuzumab) does not relate to safety or clinical data concerns.
“In the CRL [complete response letter], the FDA highlighted the need for additional technical information,” Pfizer spokesperson Thomas Biegi told us.
“Pfizer is diligently working to address the items outlines in the complete response letter and will resubmit its BLA for PF-05280014 as soon as the FDA’s considerations have been fully addressed,” he added.
Roche and Genetech’s Herceptin is indicated to treat HER2-positive breast and gastric cancers, and was without competition in the US until last year.
In December 2017, the FDA approved Mylan and Biocon’s biosimilar version of the trastuzumab drug – Ogivri.
The approval decision came several months later than expected after the FDA pushed back its action dates by three months.
Celltrion and Teva – which are collaborating on two biosimilar candidates – have also experienced regulatory delays in the US.
Earlier this month, the FDA issued CRLs to Celltrion for its Rituxan and Herceptin biosimilar candidates.
Teva told us at the time it will “continue to work closely with Celltrion with the goal of bringing the proposed trastuzumab and rituximab biosimilars to the market in the US. Teva remains committed to gaining FDA approval and to bringing these products to market.”