Shots:

• The EMA’s CHMP has granted a positive opinion- recommending marketing authorization for HLX02 to treat HER2+ early breast cancer- HER2+ metastatic breast cancer & previously untreated HER2+ metastatic adenocarcinoma of the stomach or gastro-esophageal junction
• EC will now review the CHMP’s positive opinion- with the expected regulatory decision in next 2-3mos. Once approved- a centralized marketing authorization will be granted for all EU Member States- Iceland- Norway and Liechtenstein
• HLX02 is a biosimilar mAb- developed & manufactured by Henlius while it will be distributed and marketed by Accord across the EU. HLX02 shows high bio similarity in terms of quality- safety and efficacy to its reference product- Herceptin 

Click here ­to­ read full press release/ article | Ref: Business wire | Image: Henlius