– 54-week results of Remsima showed comparability with original reference product
INCHEON, South Korea I June 16, 2013 I In the EULAR 2013, Celltrion disclosed extended clinical trial phase 1 & phase 3 study results through a poster session and oral presentation. According to these study result, RemsimaTM demonstrated clinical comparability to its original reference product in the week 14, week 30, and week 54 stages through all categories, including efficacy and safety profiles, and did not show any clinical difference.
In particular, the clinical study revealed that between patient groups using Remsima or the original product, there was no statistically significant difference in the ratio of patients who developed Anti-Drug Antibodies (ADAs).
To Celltrion’s honor the PLANETAS study of Remsima was invited to EULAR 2013 satelite symposium and poster session. EULAR is one of the world largest rheumatology congresses, and more than 14,000 medical doctors, health professionals, and clinical trial experts participate in EULAR and more than 1000 new study results are disclosed annually.
As a representative from EULAR, Dr. Jacques-Eric Gottenberg of the Strasbourg (France) University Hospital commented “Remsima proved comparability with its respective original drug in all clinical study categories”
Celltrion’s satellite symposium “The Rise of Biosimilar mAbs: The New Era of Biologic Therapy in Rheumatology” which was held on June 13th was chaired by Professor Maurizio Cutolo M.D., who serves as a President-elect of the EULAR after having been appointed to this position in 2010. Professor Cutolo said that Remsima is the world’s first biosimilar mAb to qualify to the strict and complex EMA biosimilar guideline. He added approval of RemsimaTM is synonymous to new alternatives costly biologic therapies.
Professor Cutolo explained “Biosimilars are being highlighted as alternatives to reduce consistently increasing healthcare expenditures while balancing the growing disparity in biologic use advanced and third world nations.” He added “Celltrion’s RemsimaTM is a well-situated to provide a real alternative to solving these problems.”
About Celltrion Inc. & Celltrion Healthcare
Headquartered in Incheon, South Korea, Celltrion Group is leading biopharmaceutical company, specializing in monoclonal antibody biosimilars and novel biopharmaceuticals. Celltrion Inc. focuses on the development of high quality biosimilars and novel antibody therapeutics that target various viral diseases such as pandemic/seasonal influenzas and rabies and is planning for the launching of their biosimilar drugs starting in 2012. Celltrion Healthcare conducts the marketing and sales activities for the distribution of Celltrion’s biopharmaceutical products. For more information, please visit www.celltrion.com and www.celltrionhealthcare.com.
About Remsima
Remsima is the world’s first biosimilar mAb to receive regulatory approval based on global clinical trial results. Celltrion received MFDS MAA (former KFDA) approval for Remsima in July, 2012. The company recently completed oral explanation, the last step in getting MAA approval for Remsima from the European Medicines Agency
SOURCE: Celltrion
