U.S. FDA to review Teva and Celltrion's cancer biosimilar drug

Celltrion Pharm

31/07/2017 13:59

JERUSALEM, July 31 (Reuters) - Teva Pharmaceutical 
Industries  TEVA.TA  and South Korea's Celltrion  068270.KQ  
said on Monday the U.S. Food and Drug Administration has 
accepted for review a biologics application for a biosimilar 
drug to treat breast cancer. 
    The companies said the FDA has accepted the filing of CT-P6  
with regulatory action expected in the first half of 2018. 
 urn:newsml:reuters.com:*:nBwc10YFha 
    CT-P6, already approved by the Korean Ministry of Food and 
Drug Safety, is a biosimilar -- a copy of a biotech drug -- to 
Roche Holding's  ROG.S  breast cancer and gastric cancer 
treatment Herceptin. Earlier this month, an advisory panel to 
the FDA recommended approval of a Herceptin biosimilar from 
Mylan  MYL.O  and Biocon  BION.NS . 
    Sales of Herceptin were 3.54 billion Swiss francs ($3.65 
billion) in the first half of 2017. 
    Celltrion and Teva last year entered into an exclusive 
partnership to commercialise CT-P6 as well as CT-P10 -- a 
biosimilar to Roche's blockbuster biotech cancer drug Rituxan -- 
in the United States and Canada. The FDA is also reviewing a 
Biologics Licence Application for CT-P10, with action expected 
in the first half of 2018. 
   ($1 = 0.9687 Swiss francs) 
 
 (Reporting by Steven Scheer) 
 ((steven.scheer@thomsonreuters.com; +972 2 632 2210; Reuters 
Messaging: steven.scheer.thomsonreuters.com@reuters.net; 
Twitter: @StevenMScheer)) 
 
Keywords: TEVA PHARM IND CELLTRION/BIOLOGICS