As Celltrion Healthcare announces the launch of the biobetter version of Remsima (Remsima SC) in Brazil, the company shared the phase 3 plan for its ocrelizumab biosimilar to treat multiple sclerosis (MS).
Celltrion Healthcare shared 2 announcements, including the Brazilian launch of Remisma SC, a biobetter of the company’s infliximab biosimilar (Remsima) that allows for subcutaneous administration, and a phase 3 plan for an ocrelizumab biosimilar.
Brazilian Launch of Remsima SC
Celltrion launched Remsima SC in Brazil, the largest pharmaceutical market in South America, as reported by the Korea Herald.
Remsima SC is the only infliximab product in the world that allows for subcutaneous administration and is unique as a biobetter in that it is an improvement to a biosimilar rather than an originator product. Biobetters are a class of follow-on biologic products that are intentionally altered to improve clinical effects, allow for more time in between doses, or enhance tolerability. Subcutaneous administration can allow for more convenient administration compared with intravenous administration.
The biobetter is indicated for inflammatory bowel disease, which is an umbrella term for Crohn disease and ulcerative colitis. Remsima SC was approved by the Brazilian Health Regulatory Agency in November 2022.
Celltrion will be responsible for direct sales of Remsima SC in Brazil, and the company said that it increased the number of staff members at its Brazil office to improve marketing capabilities for the biobetter. The original Remsima and Truxima, Celltrion’s rituximab biosimilar, have secured 84% and 70% market share in their respective markets in Brazil.
Celltrion said that it plans to increase sales of Remsima SC in Brazil before expanding in other countries because Brazil accounts for than half of the South American pharmaceutical market. The company predicted that many existing patients taking Remsima will switch to Remsima SC.
“(Celltrion Healthcare) plans to introduce Remsima SC in Mexico, Colombia and Peru first during the second half this year, where the company has regional offices,” said a Celltrion Healthcare official.
Phase 3 Plan for MS Biosimilar
In addition, Celltrion said that it submitted a phase 3 investigational new drug (IND) plan to the FDA for CT-P53, an ocrelizumab candidate referencing Ocrevus that would be used to treat multiple sclerosis (MS), according to a report from Korea Biomedical Review.
The phase 3 clinical trial will include 512 patients from around the world with recurrent palliative multiple sclerosis and will assess the effectiveness, pharmacokinetics, and safety between the biosimilars and the reference product.
Ocrevus is an autoimmune disease treatment developed by Roche that is used to teat recurrent MS and primary progressive MS. As of 2022, the originator has maintained its status as the top selling MS treatment, with sales reaching about $6.8 billion, $5.1 billion of which is attributed to the US market alone. The US market represents over 70% of the total ocrelizumab market.
“We plan to accelerate the development of the product based on the unique experience and know-how accumulated in the field of autoimmune diseases by submitting the IND of CT-P53 to global regulators,” a Celltrion representative commented.