The approval follows the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment […]Read More
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
The company has launched the Remsima SC, a biosimilar referencing Janssen’s Remicade (infliximab) on Apr 27, 2020. The clinical study demonstrated Remsima SC has similar results in efficacy and safety compared to the IV formulation The launch followed market releases of the product in Germany and the UK in Feb and Mar’2020 respectively. Before the […]Read More
Shots: The KFDA has approved Celltrion’s Remsima SC for RA while the company is planning to seek approval for IBD within the year through the change permit procedure and is expected to be available to the Korean patients following the completion of the permit for the addition of IBD indications Additionally, Celltrion has filed an […]Read More
Shots: The clinical study involves assessing the PK, efficacy, and safety of CT-P13 SC vs CT-P13 IV in 131 patients with active CD & UC for 1yr. Following loading doses of IV 5mg/kg @0 & 2wks., patients were randomized @6wks. to receive either SC 120/240 mg q2w or continued IV 5 mg/kg q8w, @30wks. IV […]Read More
Shots: The approval is based on P-I/III study assessing PK, efficacy and safety of Remsima/CT-P13 SC + MTX vs CT-P13 IV in patients with active RA with inadequate response to DMARDs, results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks. The approval […]Read More
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