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Open-label extension of PLANETRA (additional one year), crossover study result support Remsima


Open-label extension of PLANETRA (additional one year), crossover study result support Remsima’s interchangeability with its original reference drug.

SAN DIEGO, US, Oct 29, 2013.

Celltrion Inc. revealed the crossover study result of the world’s first biosimilar mAb, Remsima, at the American College of Rheumatology (ACR) 2013 conference. The study result demonstrated that patients being administered with infliximab and switching to CT-P13 (Remsima, Inflectra) showed no differences in efficacy or side-effects, which attracted the attention of rheumatologist attendees from all over the world.

The aforesaid crossover study, which was an open-label extension of the previous PLANETRA study(Celltrion received world’s first biosimilar mAb approval with the PLANETRA study results), measured efficacy and safety of CT-P13 over a two year period in patients with rheumatoid arthritis and ankylosing spondylitis. The crossover study compared the differences between two patient groups - a patient group that was continually treated with CT-P13 and the other patient group that changed treatment from the original reference drug to treatment with CT-P13.

Both patient groups were comprised of rheumatoid arthritis and ankylosing spondylitis patients who took part in the crossover study had been given CT-P13 or the original reference drug for a period of one year and then for the subsequent one year, all 606 patients (of both groups) were treated with CT-P13. 304 patients (out of 606 patients) who were given the original reference drug for the first year were given CT-P13 for the following year. The result showed that there was no significant difference between the two patient groups in efficacy and safety profile.

The study result is quite remarkable for biosimilar companies as large pharmaceutical companies which have previously developed original products have been raising efficacy and safety issues about patients switching from original drugs to biosimilars due to biosimilars not being identical with their original reference drugs. The crossover study result, however, refutes this argument by showing comparable efficacy and safety profile in switching from original reference drug to CT-P13. This result will serve to actively bolster countries or hospitals which incorporate a tender process where only one kind of active pharmaceutical ingredient drug can be acquired. These countries and hospitals would be free to select biosimilars as viable substitutes.

An official from Celltrion elaborated: “Rheumatoid arthritis and ankylosing spondylitis are refractory diseases which not only affect the quality of a patient’s life, but also place enormous burdens on patients with a high cost of healthcare. This crossover study result evidences Remsima’s interchangeability. Therefore, this study indicates that not only new patients in need, but also patients who had been previously using the original drug, can all benefit from equally effective treatment at a more affordable price.”

In addition, Celltrion revealed a study result of treatment on quality of life measured from a health assessment questionnaire from a randomized, double-blind trial in patients with active rheumatoid arthritis. Improvement in patients’ quality of life were also comparable with the original reference drug. This result is meaningful because Remsima not only showed comparability in clinical categories which is measured in statistics, but also showed comparability in improvement of actual patient’s quality of life.

The ACR is one of the largest global rheumatology conferences along with EULAR, with more than 15,000 medical doctors, health professionals, and clinical trial experts participating annually. Celltrion exhibited study results through four presentations which attracted much attention throughout the ACR society highlighting Celltrion as a leading biosimilar company. 

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