thinkpool

2월 14일에 발간된 thePharmaletter이라는 발간지를 보니 Remsima SC 관련 임상 발표가 이번에 비엔나에서 열린 ECCO (Eurepoen Crohn's and Colitis Organization, 유럽 크론병 및 대장염 기구)의 2020년 연례학회에서 가장 주목할 만한 연구발표초록 (the highlights of ECCO)의 하나로 선정되었다고 하는군요. 또한 연구책임자와 셀트리온에 의하면 기존 유럽에서 승인된 류마티스 관절염 이외에도 염증성 장염에 대한 RemsimaSC의유럽 승인이 2020년 중반까지는 결정될것으로 예상된다고 합니다. 모두 고무적인 소식들 입니다.  

 https://www.thepharmaletter.com/article/celltrion-s-subcutaneous-remicade-biosimilar-nears-new-indication

Decision 'within months'

Shomron Ben-Horin, department of gastroenterology, Chaim Sheba Medical Center in Israel, and one of the lead investigators of the trial, said: “These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options.

“It is exciting to hear that the abstract has been sel ected as one of the highlights of ECCO and I highly anticipate the approval decision for the inflammatory bowel disease indication in the coming months.”

Celltrion’s biosimilar, known as Remsima or CT-P13, was approved in the SC form for patients with rheumatoid arthritis in November, 2019, and now the company is hoping for approval in the inflammatory bowel disease indication in mid-2020.