Shots:

• The EMA’s CHMP has adopted a positive opinion for approval of CT-P17- biosimilar referencing Humira- recommending its approval for all available indications
• Celltrion filed MAA of CT-P17 with the EMA in Mar’2020. The EC will review the CHMP’s positive opinion which would give a final marketing approval in 1-3mos.
• If approved- Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation

 ­ Ref: PulseNews | Image: Celltrion