Firm?s second biosimilar approval following Remsima in 2015 in market worth approximately KRW 300 billion?

- Expanding biosimilar market by establishing stronghold in Brazil for further influence in Central-South American markets

INCHEON, South Korea -?Celltrion announced the approval of Herzuma (project name: CT-P6, trastuzumab-pkrb), a mAb biosimilar for breast and gastric cancer, from the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria) on May 20, 2019. The ANVISA has approved the use of 150mg and 440 mg of Herzuma for all indicated cases including early-stage breast cancer, metastatic breast cancer and metastatic gastric cancer. Herzuma?s reference biologic is ?Herceptin? developed by Genetech and commercialized by Roche, which makes up a KRW 300 billion market in Central and South Americas. Celltrion will schedule the launch of Herzuma with Celltrion Healthcare in consideration of global business circumstances. Celltrion plans to make inroads into Brazil, which constitutes more than a half of KRW 520 billion Herceptin market in Central-South Americas and expand its presence in other nations in the region. Celltrion?s advancement in Central-South Americas is expected to gain more momentum when the ANVISA finalize the approval of Truxima, another Celltrion biosimilar to Rituximab, a hematologic malignancy treatment which currently forms a KRW 250 billion market in the region. Celltrion believes that Truxima will effectively supplement Remsima and Herzuma in helping the firm secure a leading market position in the Central-South American biosimilar market. The Brazilian government?s heath care system is burdened with the costs of importing 80% of the nation?s pharmaceuticals and spending 32% of its entire pharmaceutical budget on antibody pharmaceuticals. Brazil presents biosimilars with favorable opportunities because 80% of the pharmaceuticals are sourced through tenders by the federal and the local governments. A Celltrion representative has said, ?In Brazil, there is also a demand to substitute expensive original pharmaceuticals with biosimilar drugs with proven safety and efficacy to reduce health care costs just as in the Europe and other nations with well-developed health care systems. We will do our best to introduce Herzuma in Brazil and other Latin American markets as quickly as we can to replicate its fast success in the Europe.?