Samsung Bioepis Launches Biosimilar Etanercept in Brazil

Samsung Bioepis has launched its biosimilar etanercept, SB4, in Brazil. The biosimilar, which is being sold as Brenzys, was approved in Brazil in 2017 to treat rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and nonradiographic axial spondyloarthritis.

The biosimilar is being supplied to the country’s public health system through a partnership between Samsung Bioepis and local partner organizations Bionovis and Bio-Manguinhos/Fiocruz. Under the partnership, Samsung Bioepis will supply the product for sale to the health system for 10 years, during which it will also provide a technology transfer in order to eventually transition manufacturing responsibilities to local facilities in Brazil.

The arrangement is part of a program, known as the Partnership for Productive Development, that brings together government and the private sector to develop strategic products of interest to the Brazilian health system. The program, first introduced in Brazil in 2008, aims to expand access to medicine while providing companies guaranteed purchases of their drug products by the national healthcare system, which provides care to approximately 75% of the nation’s population.

“We are excited to provide our high-quality biosimilars to patients across Brazil, and look forward to working with our local partners to enhance patient access to high-quality healthcare. Equally important, by sharing our scientific knowledge with our local partners, we hope to do our part in contributing to the long-term development of the Brazilian biopharmaceutical industry,” Sang-Jin Pak, senior vice president and head of commercial division, Samsung Bioepis, said in a statement announcing the biosimilar’s launch.

The biosimilar etanercept is also approved in the United States (under the name Eticovo) and in multiple other territories (under the Brenzys brand as well as under the name Benepali). While the etanercept biosimilar is widely used in regions such as the European Union, no launch date for the product has been announced for the US marketplace, and concerns linger about when the product will be able to reach US patients; a recent decision in a long-running legal battle related to the reference etanercept (Enbrel) and a different biosimilar (Sandoz’s Erelzi) upheld the validity of 2 patents on Enbrel that will not expire in the United States until 2028 and 2029, respectively.