Celltrion launches in Canada and wins tender in Brazil
Celltrion Healthcare, based in the Republic of Korea, has made some progress in its biosimilars commercial efforts, launching its adalimumab biosimilar (Yuflyma) in the Canadian market and obtaining exclusive marketing rights in several regions of Brazil.
Canadian launch of Yuflyma
Celltrion has launched its high-strength, citrate-free (100 mg/ml) formulation of its benchmark biosimilar Humira across Canada. Yuflyma is available as an auto-injector pen and a pre-filled 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, Crohn’s disease in adults, ulcerative colitis in adults, hidradenitis suppurativa, plaque psoriasis, uveitis in adults and pediatric uveitis.
“With the specific characteristics of Yuflyma, such as a lower injection volume and a high-concentration, citrate-free formulation, it may provide additional clinical benefits to patients,” said John K. Marshall, MD, Professor of Medicine and director of the division of gastroenterology at McMaster University, in Celltrion’s statement.
Celltrion has also launched Celltrion Connect, a patient-focused support program to provide advice on navigating reimbursement, financial assistance, injection and nursing support services, and pharmaceutical support services for patients. and health care providers in Canada.
Tender won in Brazil
Celltrion also announced that it has 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.
Tendering systems are designed to encourage competition between companies for the chance to win a contract, also known as a tender, for the exclusive or near-exclusive rights to supply a biological or biosimilar product to an area. location or health care facility. Companies submit price offers to the organizers of the tender and a contract is awarded to the lowest priced product or products, depending on whether or not the system allows multiple winners. Several European markets, including France and the UK, have adopted competitive bidding systems.
The tender offer would allow Remsima to be supplied to patients through the federal and state governments, enabling approximately 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, Crohn’s disease, plaque psoriasis, and ulcerative colitis.
“Winning the RFP is an important step in expanding patient access to effective and affordable biosimilar medicines in countries like Brazil and Mexico, which are 2 of America’s largest pharmaceutical markets. Latin,” said HoUng Kim, PhD, head of the Medical and Darketing Division at Celltrion, in a company statement.
In addition, Celltrion has obtained the exclusive rights to commercialize Remsima in Peru, Chile and Costa Rica for the last 3 to 4 years following the obtaining of calls for tenders in these countries.
Remsima is the third biosimilar developed by Celltrion to win a tender for the Brazilian market. In 2021, Celltrion signed an agreement with the Brazilian Ministry of Health to supply Herzuma, the company’s biosimilar trastuzumab referencing Herceptin, and Truxima, its biosimilar rituximab referencing Rituxan, to the Brazilian market. Celltrion also won a takeover bid from the Institute of Health for the Welfare of the United Mexican States for Truxima for 1 year.
In order to further establish the companies in Latin America, Celltrion is establishing an entity in Brazil and Mexico to manage the sales and marketing activities of its biosimilars in the region.