Celltrion amends timeline for rituximab biosimilar
Celltrion Inc. (KOSDAQ:068270) said it plans to start a Phase III trial of CT-P10, its biosimilar rituximab, in 2H13. Celltrion had planned to conduct Phase I and Phase III testing simultaneously, but decided to run the trials sequentially after receiving advice from regulatory agencies. The ongoing Phase I trial is slated to complete this month. Celltrion was down KrW6,300 (15%) to KrW36,850 on Thursday after an analyst and Bloomberg reported that the company discontinued a Phase III trial of CT-P10, citing the EU Clinical Trials Register. Celltrion could not be reached for comment.
Celltrion also said it expects a decision in June on an MAA for Remsima, the company's biosimilar version of autoimmune drug infliximab. The company said EMA had no questions in the last process of the review of the MAA that would affect the product's approval. Korea's Ministry of Food and Drug Safety (MFDS) approved Remsima last year. The product is partnered with Hospira Inc. (NYSE:HSP), which was down $0.13 to $31.16 on Thursday. ...