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A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.
Celltrion Healthcare says it is committed to developing laboratory tests that will determine both drug and antidrug antibody (ADA) levels in the blood, the company said in a July 5, 2016 press announcement. The development of these tests will better enable physicians to identify when patients on an antitumor necrosis factor (anti-TNF) drug require a change of dose or a switch to a different treatment in the class, the company noted.
This commitment may be partially the result of a study on rheumatoid arthritis presented at the 2016 European League Against Rheumatism annual congress (EULAR). The study indicates high levels of infliximab antidrug antibodies at the beginning of treatment were associated with a poor response during later stages, Celltrion noted in a press announcement.
“Biologics and biosimilars tested with advanced analytical methods to assess drug and ADA levels could be used for developing tailored treatments, said Man Hoon Kim, president of Celltrion Healthcare, in a press announcement. “Celltrion is fully committed to support this type of research to develop affordable laboratory tests, or kits, for routine monitoring that allows personalized infliximab treatment according to the disease status of individual patients.”
The company recently extended its Remsima studies, PLANETRA AND PLANETAS, up to 102 weeks. The extension studies indicated Remsima was effective over two years and that the efficacy, safety, and immunogenicity of Remsima and the reference product were comparable, Celltrion says.
FDA approved Celltrion’s Inflectra (infliximab), a biosimilar to Janssen Biotech’s Remicade (infliximab) in April 2016. Inflectra is the first FDA approved monoclonal antibody biosimilar, and is marketed in Europe as Remsima. The drug was approved in the US for all indications except for Remicade’s indication for pediatric ulcerative colitis, which is covered by orphan drug exclusivity until Sept. 23, 2018.