April 27, 2024

• 

[THE INVESTOR] Celltrion's Rituxan biosimilar is expected to hit European market earlier than planned, the company said Nov. 25.

Mundipharma, which has distribution license for Truxima in major European countries including the UK, Italy and Germany, expects the drug to receive approval from European Medicines Agency shortly.

“We plan to commercialize Truxima in Europe in sequential order starting from the UK in the first half of 2017,” Warren Cook, commercial lead at Mundipharma said during a meeting hosted by Celltrion with its global partners in Incheon.

Celltrion’s Truxima is a biosimilar referencing Roche’s blockbuster lymphatic cancer treatment Rituxan (rituximab).

This is the first time that Celltrion mentioned a detailed time frame for the drug’s launch in the European market. The firm had said it will be sometime in 2017.

Entering markets earlier is crucial for biosimilar products as a growing number of companies are producing the less costly imitation versions of blockbuster biologic drugs that have lost patent protection.

Truxima, also known as CT-P10, has been approved for the treatment of Non-Hodgkin’s Lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis, according to Celltrion.

On Nov. 17, the Rituxan biosimilar was granted sales approval by Korea’s Ministry of Food and Drug Safety. Celltrion also plans to submit Truxima to the US Food and Drug Administration by the end of this year.

By Park Han-na (hnpark@heraldcorp.com)