Overseas Successes: Celltrion Launches in Canada, Wins Tender in Brazil

Celltrion Healthcare, based in the Republic of Korea, has made a couple advances in its biosimilar business endeavors, launching its adalimumab biosimilar (Yuflyma) on the Canadian market and winning exclusive marketing rights in several areas of Brazil.

Canadian Launch of Yuflyma

Celltrion launched its high-concentration, citrate-free formulation (100 mg /ml) of its biosimilar referencing Humira across Canada. Yuflyma is available in an auto-injector pen and in a prefilled syringe.

Yuflyma received regulatory approval from Health Canada in December 2021 for 10 indications including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohns disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

“With the specific features of Yuflyma, such as lower volume of injection and a high-concentration formulation without citrate, it may provide additional clinical benefits for patients," said John K. Marshall, MD, professor of medicine and director of the division of gastroenterology at McMaster University, in Celltrion’s statement.

Celltrion also launched Celltrion Connect, a patient-focused support program intended to provide guidance with reimbursement navigation, financial assistant, injection and nurse support services, and pharmacy support services for patients and health care providers in Canada.

Tender Wins in Brazil

Celltrion also announced that it had won a tender offer presented by the Brazilian Federal Government for the purchase of Remsima, an infliximab biosimilar referencing Remicade.

The company won 12 state bids in Brazil to supply the biosimilar, including the bid for São Paulo, the largest state bid available in the country.

Tenders systems are designed to encourage competition among companies for the chance to win a contract, also known as a tender, for exclusive or near-exclusive rights to supply a biologic or biosimilar to a geographic area or health care setting. Companies submit pricing bids to the tender organizers and a contract is awarded to the lowest-cost product or products, depending on whether the system allows for multiple winners. Several European markets, including France and the United Kingdom, have adopted tender systems.

The tender offer would allow for Remsima to be supplied to patients through the federal and state governments, allowing about 2 thirds of the total Brazilian population requiring treatment with infliximab products to have access to the biosimilar.

Infliximab products are used to treat several rheumatic conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohns disease, plaque psoriasis, and ulcerative colitis.

“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 2 of the biggest pharmaceutical markets in Latin America,” said HoUng Kim, PhD, head of the Medical and Darketing Division at Celltrion, in a company statement.

Additionally, Celltrion has obtained exclusive marketing rights for Remsima in Peru, Chile, Costa Rica for the previous 3 to 4 years as a result of winning tender bids in those countries.

Remsima is the third biosimilar developed by Celltrion to win a tender for Brazil’s market. In 2021, Celltrion signed an agreement with the Brazilian Ministry of Health to supply Herzuma, the company’s trastuzumab biosimilar referencing Herceptin, and Truxima, its rituximab biosimilar referencing Rituxan, to the Brazilian market. Celltrion also won a tender offer by the Institute of Health for the Welfare of the United Mexican States for Truxima for 1 year.

To further establish the companies in Latin America, Celltrion establishing an entity in Brazil and Mexico to manage sales and marketing activities for its biosimilars in the region.