Celltrion Healthcare today announced that the company has won a tender offer by the Brazilian Federal Government for the purchase of the world’s first monoclonal antibody biosimilar Remsima® (infliximab) in Brazil. In addition, the company has won 12 State bids in Brazil to supply Remsima®, including a bid in Sao Paulo, which is the largest of Brazil's state bids.

In 2021, the company has signed an agreement with the Ministry of Health to supply two of its anticancer therapeutics Herzuma® (trastuzumab) and Truxima® (rituximab) to the Brazilian market. Together with Truxima® (rituximab) and Herzuma® (trastuzumab), Remsima® (infliximab) will be the third biosimilar product that Celltrion Healthcare is to supply to the Brazilian market by winning a tender. 

In addition to winning a bid for Remsima® by the Brazilian Federal Government, Celltrion Healthcare also won a tender offer by the Institute of Health for the Welfare of the United Mexican States (INSABI) for the purchase of Truxima® (rituximab) for one year.

“The winning of the bid is an important milestone to broaden patient access to effective and affordable biosimilar medicines in countries like Brazil and Mexico, which are two of the biggest pharmaceutical market in Latin America,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “By supplying Remsima® (infliximab) to both the private sector and the federal and State government, we anticipate to achieve approximately two-thirds of the total Brazilian infliximab market. We have solidified our market position by exclusively supplying our biosimilar products in Peru, Chile and Costa Rica as well over the last three to four years. We are excited to adopt a direct sales strategy in the Central and South America countries in order to strengthen and expand our presence in the market and support the company’s growth.” 

As part of Celltrion’s strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Brazil and Mexico to manage sales and marketing activities for its biosimilar products.

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Notes to Editors: 

About Celltrion Healthcare 

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit:https://www.celltrionhealthcare.com 

About Remsima® (biosimilar infliximab) 

Remsima® is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including Rheumatoid Arthritis (RA) and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US Food and Drug Administration (FDA) approved CT-P13 in April 2016 under the trade name Inflectra®. Remsima® is approved in 96 countries (as of March 2022) including the US, Canada, Japan and throughout Europe. 

About Truxima® (CT-P10, biosimilar rituximab) 

Truxima® is a mAb that targets CD20, a transmembrane protein found on the surface of most B-cells. By binding specifically to CD20, Truxima® depletes B-cells by three main mechanisms: induction of apoptosis, stimulation of CDC (complement-dependent cytotoxicity) and stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity). Truxima® is approved in the EU and US for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Truxima® is the first rituximab similar biotherapeutic product to be prequalified by the World Health Organization (May 2020).