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

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

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  • The study results involves assessing of CT-P13 SC (90mg/120mg/180mg) vs CT-P13 IV (3mg/kg)  in 50 patients in ratio (1:1:1:1) with RA- followed by a P-I/III study assessing CT-P13 SC (120mg- q2w) vs CT-P13 IV in 362 patients in ratio (1:1) with RA for 30wks.
  • Collective results: @54wks. efficacy is comparable; DAS28 (CRP) and ACR20 are comparable in all cohorts; CT-P13 SC is non-inferior to CT-P13 IV- @22wks. similar ACR response- @6wk. SC 120mg safety is comparable to IV dose
  • CT-P13 is a mAb- currently being evaluated in an additional 5yrs. study for RA and ankylosing spondylitis and has received approval in the US (marketed as Inflectra) in Apr’16- in Europe (marketed as Remsima) in Sept’13- additionally in other 89+ countries

Ref: BusinessWire | Image: Celltrion

Click here to­ read the full press release 

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