Samsung Bioepis said that it has received sales approval for Brenzys, an Enbrel biosimilar product, from Brazil's Ministry of Health.
|Samsung Bioepis headquarters in Songdo, Incheon.|
In Brazil, more than 90 percent of autoimmune disease treatments such as Enbrel, Humira, and Remicade are available through the nation's productive development partnership (PDP) program.
The PDP is a program where a global biopharmaceutical company, a Brazilian pharmaceutical company, and a national research institute enter into a three-party partnership. Through the partnership, the global biopharmaceutical company will supply its products while transferring its production technology to Brazilian pharmaceutical companies and research institutions for a specified period.
According to the company, this is the first time a local company has entered into a PDP program.
Under the PDP program, Samsung Bioepis has signed a three-party agreement with Bionovis, a Brazilian pharmaceutical company, and Bio-Manguinhos, a Brazilian research institute, to transfer product production technology.
The company will directly supply Brenzys for the first 10 years, and receive royalties on a portion of sales for the following 10 years.
"The company has been recognized for its global R&D capabilities based on process innovation," Samsung Bioepis CEO Ko Han-sung said. "We expect to expand the opportunities for high-quality biopharmaceutical treatment in Brazil, which has the largest pharmaceutical market in Latin America."
Brazil has had an average annual growth of more than 9.5 percent over the past five years, while the market size is expected to reach $29.7 billion by 2021.