Celltrion receives approval for biosimilar Mabthera in South Korea

According to The Korea Herald, South Korean biopharmaceuticals company Celltrion said on Thursday that its Mabthera biosimilar has been granted sales approval by Korea’s Ministry of Food and Drug Safety.

Celltrion’s Truxima is a biosimilar referencing Roche’s blockbuster lymphatic cancer and rheumatoid arthritis treatment Mabthera/Rituxan (rituximab). The product was named CT-P10 during the development stage and has been approved for the treatment of Non-Hodgkin’s Lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in Korea.

It is Celltrion’s third biosimilar to receive authorization in Korea alongside the company’s Remicade biosimilar approved in 2012 and Herceptin biosimilar approved in 2014, Korea Herald reports.

The Korean company submitted Truxima to the EMA for approval in October 2015. It expects to begin selling the drug in Europe upon the drug’s expected approval in 2017.

“We are expecting to reap ‘first mover’ advantages from being the first company to introduce a Rituxan biosimilar in the global market,” Celltrion said in a statement.

Celltrion plans to file Truxima for review by the US Food and Drug Agency by early next year and become the first to introduce a Rituxan biosimilar in the US, the world’s biggest market for biologic drugs.

Source: Korea Herald