Celltrion to Initiate P-I trial for CT-P39 (biosimilar, omalizumab)

Celltrion Reports Results of CT-P13 SC (infliximab, biosimilar) in a Clinical Study for Rheumatoid Arthritis #EULAR2019

Shots:

  • Celltrion plans for the onset of P-I trial for CT-P39 referencing Xolair, and further plans to enter P-III trial in H1’20 with its expected commercialization by 2020
  • The P-I trial will involve assessing of CT-P39,EU-licensed Xolair and US-licensed Xolair evaluating PK and safety in 171 patients in with its expected completion in Aug’20. In Dec 2018, Celltrion began to develop CT-P39 and is focused on the US markets accounting for ~70% of the branded drug’s global sales
  • CT-P39 is a mAb targeted for the treatment of allergic asthma and chronic urticaria. According, to IQVIA, the global sales Xolair reached 3.3 trillion won ($2.7 billion) in 2018

Click here to read full press release/ article | Ref: Celltrion | Image: Twitter