The 15th Annual Scientific Conference on Rheumatology – VRA 2018 took place on April 20-21, 2018 at Muong Thanh Hotel and Thao Nguyen Hotel, Moc Chau, organized by the Vietnam Rheumatology Association.
The conference attracted more than 700 delegates who are leading experts, professors, doctors, doctors, nurses in the field of Rheumatology and related disciplines across the country to attend. In addition, the Conference was also honored to welcome guests who are representatives of the Ministry of Health, Vietnam Medical Association, Son La Provincial People’s Committee, Son La Department of Health… in the opening program on April 20. 2018.
The main scientific conference program includes many overview topics and updated scientific reports on advances in the field of rheumatology, orthopedic trauma in Vietnam as well as in the world, presented by Vietnamese and international experts. One of the delegate’s topics of interest was new therapies in joint treatment, especially biological drugs.
On this occasion, Viet Phap also respectfully introduce the new product in our exhibition booth and a report in the main scientific session, presented by Dr. Nicholas Sohn with the theme: “Remsima – The 1st world biosimilars monoclonal antibody (mAb) approved by EMA and FDA.”
Bài báo cáo tập trung làm rõ khái niệm và vai trò của một thuốc Sinh học tương tự, quy trình phê duyệt khắt khe của EMA và FDA, sự chuyển đổi phác đồ điều trị từ thuốc sinh học gốc sang thuốc sinh học tương tự như thế nào và đặc biệt là các bằng chứng lâm sàng chứng minh biosimilar Remsima® có độ tương tự cao so với thuốc sinh học tham chiếu Remicade xét về chất lượng, độ an toàn và hiệu quả điều trị.
Biosimilar drugs are quite familiar in Europe, the USA, Japan and many other countries around the world. In addition, the role and position of biosimilars in the treatment of autoimmune diseases have also been recognized for the fact that the drug has the same therapeutic effect as the reference biological drug but at a much lower cost. However, a biosimilar is still a relatively new concept for Vietnamese managers and medical professionals. Regulations on the registration and management of Biosimilar drugs are still in the process of being developed and need more time to be finalized. Therefore, although Remsima – a product of Celltrion, Inc. has been approved by the EMA as a biosimilar of Remicade since June 2013 and by the USA FDA in April 2016 with all the same indications as Remicade (RA, ankylosing spondylitis, arthritis psoriasis, Crohn’s disease and ulcerative colitis), but in Vietnam in March 2017, this product was only licensed as a biological product, not yet recognized as a biosimilar.
As of early 2018, Remsima has been licensed in 85 countries and is in circulation in more than 60 countries. More than 150,000 patients have been treated with this product after only 3 years of being on the world market. The safety and efficacy of the drug are comparable to the originator Infliximab, as demonstrated by a series of large-scale, multicenter, randomized clinical studies such as PLANETAS, PLANETRA, NOR-SWITCH, and numerous other studies. In particular, NOR-SWITCH is a double-blind, randomized, controlled, phase IV study involving 482 patients in all indications with a research budget of up to €2.2 million, 100% funded by the Government. The government of Norway, has demonstrated that Remsima is as safe and effective as infliximab. In addition, efficacy and safety were comparable between the maintenance group on the originator Infliximab and the switch from conventional infliximab to Remsima during 52 weeks of treatment.
Therefore, in many countries around the world, especially European countries, Remsima has dominated the market for the infliximab group. According to the IMS report, in the fourth quarter of 2017, Remsima accounted for 53% of the infliximab market share in the world. This figure in Norway is 97%, Denmark 96%, Finland 93%, UK 80%, Netherlands 711%. In Singapore, in March, the Ministry of Health announced that it would include biosimilar Remsima on the reimbursement list to completely replace Remicade after December 31, 2018.
It can be said that Remsima has quickly affirmed its role and position as a high-quality biosimilar in the field of biological drugs, based on its treatment effectiveness, high safety as well as reasonable price. It is hoped that this product will open up opportunities for many patients with joint, psoriasis and digestive diseases in Vietnam to access treatment with high-quality biosimilars soon.