Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (biosimilar, trastuzumab)

 Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (biosimilar, trastuzumab)

Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (trastuzumab, biosimilar)

Shots:

  • The acceptance follows P-III study demonstrating bio-similarity data between HLX02 and reference product trastuzumab sourced from EU in 649 patients with HER2+ m-breast cancer and P-I study resulting equivalence in PK & safety studies b/w HLX02 and reference trastuzumab sourced from both EU and China
  • In Jun’18, Henlius granted exclusive commercialization rights of HLX02 to Accord across 53 countries including UK, Germany in Europe. HLX02 & HLX03 (adalimumab, biosimilar) both are under NMPA review in China
  • HLX02 is the first biosimilar of trastuzumab developed in China, indicated for HER2+ early-stage breast cancer, HER2+ metastatic breast cancer, untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer

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

Tuba Khan

Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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