Celltrion's RamsimaSC, the world's only infliximab subcutaneous injection drug for autoimmune disease treatment, has received a green light for market expansion in Brazil, the largest pharmaceutical market in Latin America.
On the 17th, Celltrion announced that the Technical Committee (CONITEC) under the Brazilian Ministry of Health recently recommended approval to register the infliximab subcutaneous injection formulation as a new item in the federal government's public healthcare system. After completing administrative procedures, the final listing is expected to be completed in the second half of this year.
Through this listing, a public market for the infliximab subcutaneous injection formulation, which did not previously exist in Brazil, will be newly established, and since RamsimaSC is the only existing product, it is expected to quickly capture this market. Brazil, with a population of over 210 million, is considered a key country accounting for more than half of the Latin American pharmaceutical market.
The existing intravenous injection product, Ramsima, also supplied more than 570,000 bottles in Brazil last year, including winning federal government bids, covering over 80% of the market. Given that RamsimaSC, the only infliximab subcutaneous injection drug, is expected to dominate federal government bids, the synergy between the two drugs is anticipated to accelerate prescription expansion. Additionally, Celltrion's oncology drugs Herzuma and Truxima control more than half of the market, which is expected to further strengthen overall market dominance.
Celltrion plans to secure the Brazilian market and use it as a base to expand the RamsimaSC market to neighboring Latin American countries. In particular, the recent new listing of the infliximab subcutaneous injection item by the Brazilian federal government is expected to have a positive impact by generating public opinion on the need to introduce the product in countries such as Mexico, Chile, and Peru, which are considering registering infliximab subcutaneous injection products in their government procurement lists.
Kang Kyung-doo, Celltrion's Latin America regional manager, said, “Since the second half of last year, we have actively communicated by informing government agencies about the need to establish a market for the infliximab subcutaneous injection formulation and submitting related documents, resulting in an environment where RamsimaSC prescriptions are possible in the Brazilian market.” He added, “With the launch of the autoimmune disease treatment drug Uplima in the second half of this year, we will have three autoimmune disease treatments, and leveraging the advantage of offering diverse treatment options, we will strengthen sales activities to ensure that more Brazilian patients can access Celltrion products.”
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