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Celltrion Presents Results of CT-P17 (biosimilar- adalimumab) in P-III Study for RA at ACR 2020

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Celltrion Presents Results of CT-P17 (biosimilar- adalimumab) in P-III Study for RA at ACR 2020

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  • The P-III study involves assessing CT-P17 (40mg- q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both- 2EPs include ACR20/50/70 response rates- mean DAS28- CDAI & SDAI & EULAR (CRP) response- Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups- the safety profile is comparable
  • Additionally- comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17- the auto-injector (AI) and pre-filled syringe (PFS)

  Ref: Businesswire | Image: Celltrion

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