Teva, Celltrion partner on biosimilar commercialization

JERUSALEM and INCHEON, South Korea — Teva and Celltrion on Thursday announced a new exclusive partnership centered on commercializing two of Celltrion’s biosimilar candidates in the United States and Canada. 

 

Among Celltrion’s candidates are CT-P10, a potential biosimilar for Rituxan (rituximab) and CT-P6, a potential biosimilar for Herceptin (trastuzumab), two drugs that have combined sales of about $6.5 billion in Canada and the United States. Both potential biosimilars are currently in late-stage Phase III development, and CP-P10 was submitted to the European Medicines Agency for review last October. Celltrion plans to submite CT-P6 to the EMA this quarter for review. 

 

“This commercial partnership with Celltrion enables Teva to expand into the upcoming wave of biosimilars and build on its strong position in the biosimilar space,” Teva Global Generic Medicines president and CEO Siggi Olafsson said. “The introduction of two additional mAb biosimilar candidates into our near-term pipeline bolsters our biosimilar portfolio and continues to leverage Teva’s unique cross-functional capabilities across both specialty and generic medicines.”

 

Under the agreement, Teva will be responsible for all U.S. and Canadian commercial activities pending regulatory approval for both products, while Celltrion is responsible for completing clinical development and regulatory activities. Teva will pay Celltrion $160 million up front, with $60 million of that total being refundable or creditable under certain circumstances. 

 

“As a global biopharmaceutical leader with established products as well as a robust biosimilar pipeline and novel drugs, we are very excited about our new partnership with Teva,” Celltrion CEO HyoungKi Kim said. “Following on the heels of our global success with Remsima™ (Inflectra™), our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with proven record of quality, efficacy and safety to the reference product, we are confident that we will be able to repeat the same success in the U.S and Canada with CT-P10 and CT-P6 through our partnership with Teva.”