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Celltrion's Herceptin Biosimilar One Step Closer To US FDA Approval

 
• By Jung Won Shin

Following Oncologic Drugs Advisory Committee's recommendation for Mylan and Biocon's trastuzumab biosimilar, Celltrion and Teva's CT-P6 appear to be one of the next one in, but given the expiry of Herceptin patent in the US and other late stage trastuzumab biosimilar candidates, it could be anybody's game to launch their products first.

Celltrion Headquarters
Celltrion HQ in Incheon, South Korea • Source: Celltrion Inc.

The US FDA has accepted for review the BLA for Celltrion Inc. and Teva Pharmaceutical Industries Ltd.'s CT-P6, a proposed biosimilar to Roche's Herceptin (trastuzumab), putting the product second in line for approval.

The application could even enjoy a little second-mover advantage. On July 13, FDA's Oncologic Drugs Advisory Committee recommended Mylan NV and Biocon Ltd

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