South Korean biopharma company Celltrion said Thursday that its Rituxan 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 treatment Rituxan (rituximab). Biosimilars refer to cheaper, near-replicas of biologic drugs that have lost patent protection.
Celltrion's headquarters in Songdo, Incheon (Yonhap)
Truxima, also known as CT-P10, has been approved for the treatment of Non-Hodgkin’s Lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis, Celltrion said.
It is Celltrion’s third biosimilar to score sales approval in Korea alongside the company’s Remicade biosimilar approved in 2012 and Herceptin biosimilar approved in 2014.
Korea’s regulatory approval of Truxima is expected to pave the way for the biosimilar drug’s approval by the European Medicines Agency, Celltrion said.
The Korean biosimilar developer 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.
Meanwhile, Novartis-owned Sandoz also submitted its own Rituxan biosimilar to the EMA for approval in May this year. Pfizer and Amgen are wrapping up third-phase clinical trials of their own Rituxan biosimilars as well.
Rituxan was the world’s second best-selling biologic drug in the world, having generated worldwide sales of $7.3 billion last year.
By Sohn Ji-young (firstname.lastname@example.org