Tags : Additional

Biosimilars Regulatory

Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for

Shots: CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS, CD, UC, PsA and psoriasis. The CHMP’s positive opinion follows EC’s MAA for the therapy granted in Nov’2019 The CHMP’s opinion is based on data evaluating the PK, efficacy and safety between CT-P13 SC to CT-P13 IV […]Read More