HONG KONG – South Korean biopharmaceutical company Samsung Bioepis Co. Ltd., based in Incheon, will expand into the Brazilian market with Brenzys (etanercept), having recently signed a marketing agreement with Brazil's Ministry of Health. The drug is now available through the country's public health system, Sistema Único de Saùde (SUS).

Under the terms, Bioepis will supply the drug to the country for 10 years; then it will receive royalties from Brenzys' sales over the next 10 years.

Brenzys is a biosimilar referencing Amgen Inc.'s blockbuster TNF inhibitor, Enbrel, a treatment for autoimmune diseases. Enbrel's global sales for last year were $7.885 billion.

In December 2017, Brenzys was approved by Brazil's health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA), for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and non-radiographic axial spondyloarthritis.

The deal was based on Brazil's Productive Development Partnership (PDP), a government program to expand public access to medicine in the country. PDP supports collaborations between Brazilian and foreign pharmaceutical firms and Brazil's state-run institutes. Bioepis joined the PDP with two Brazilian partners – Bionovis SA, a biotech based in Valinhos, and Bio-Manguinhos, a government body institute based in Rio de Janeiro.

"We believe our partnership with Bionovis and Bio-Manguinhos places us in a strong position for long-term growth in the Brazilian public market, where our etanercept biosimilar has already captured significant market share," Na Yun Kim, global communication manager at Samsung Bioepis, told BioWorld. "By close collaboration and technology transfer, we hope to deliver meaningful value to health care stakeholders throughout the country."

The Korean company said it had competency over the original drug Enbrel in the Brazilian market.

"Our etanercept biosimilar has been approved for marketing in more than 30 countries, including Korea, Australia, EU member states, the U.S. and Canada. In Europe, it has been marketed for more than three years under the brand name Benepali, with more than 100,000 patients being treated with our etanercept biosimilar alone. It is the most prescribed etanercept in France, Germany, Italy, Spain and the United Kingdom, surpassing both the reference product and other etanercept biosimilars," Kim noted.

Under the government program, Bioepis will provide the biosimilar products to its local partners for sale to SUS, and also will transfer the production technology to the Brazilian partners. The Korean firm aims to gradually transfer the manufacturing responsibilities to enable local production in Brazil.

Success expected in emerging market

In Brazil, more than 75% of patients use SUS for health care coverage. While biologics represent merely around 4% of SUS' medicine, they account for 51% of the government spending on all medicinal products.

The Brazilian biotech Bionovis focuses on biologics based on recombinant DNA technology using living cells. Through partnerships with global corporations such as Merck & Co. Inc., based in Kenilworth, N.J., and Janssen Pharmaceutica NV, based in Beerse, Belgium, it develops technology to produce various monoclonal antibodies and therapeutic proteins.

It has launched anti-TNF therapy infliximab and develops diverse treatments, including trastuzumab, bevacizumab and rituximab for treatment of oncology, along with etanercept and adalimumab for treatment of inflammation and immunology.

Bio-Manguinhos, or the Immunobiological Technology Institute of Brazil, is one of the largest public producers of vaccines in Latin America. Its medical products treat yellow fever, polio, meningitis A and C, measles, mumps and rubella, rotavirus and Haemophilus influenzae type B.

The public institute is one of the 16 technical and scientific units of the Oswaldo Cruz Foundation (Fiocruz) under Brazil's Ministry of Health. It produces reagent kits for the lab diagnosis of Chagas disease, leishmaniasis, leptospirosis and AIDS, as well as diseases caused by helminths. It also manufactures biopharmaceuticals to treat hepatitis B and C and severe anemia.

Bioepis is a joint venture between Korean pharmaceutical company Samsung Biologics Co. Ltd. and U.S. biotech Biogen Inc., of Cambridge, Mass. Its pipeline includes various biosimilar candidates to treat immunology, oncology, ophthalmology and hematology. The company's products are available on five continents, including North America, Europe, Asia, Oceania and Latin America.

The company has four biosimilars marketed across Europe, which include the anti-TNF trio of Benepali, Flixabi (infliximab) and Imraldi (adalimumab), as well as an oncologic biosimilar Ontruzant (trastuzumab). The company has provided its biosimilars to more than 170,000 patients in Europe.

In the U.S. market, the company has one biosimilar, Renflexis (infliximab-abda) approved and marketed. Ontruzant received approval from the FDA in January this year, and Eticovo (etanercept-ykro) and Hadlima (adalimumab-bwwd) received FDA approval in April and July this year, respectively.

"Bioepis' Benepali successfully accounted for 40 percent of the European market three years after they launched," said Jaehoon Shin, analyst at Hanwha Investment and Securities Co. Ltd. in Korea. "This means the company's biosimilar is more competent than the original drug. Brenzys is expected to be successful in Latin America as it is an emerging market."

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