The Korean pharmaceutical company Rituximab accounts for 40% of the European market. What is the current status of domestic production?

Author: Zhao Yanwu

Recently, Korean pharmaceutical giant Celltrion announced that its product Truxima has a combined market share of 46% in the UK, France, Italy, Germany and Spain as of the second quarter of 2021, and these five countries account for approximately the European rituximab market 70% of it

According to Celltrion officials, Truxima's market share in European countries surpassed Roche for the first time as early as the fourth quarter of 2019, and Truxima is also on the rise in the United States

In the same market, the same biosimilar drugs, compared with China and South Korea, domestic companies are slightly inadequate

Twenty-one years ago, Roche's Rituxan (Rituxan) was approved to enter the Chinese market, and because of the gap in domestic drugs, it has dominated the domestic market for more than a decade

Image source: Fosun Pharma Announcement

As the first rituximab biosimilar drug approved for marketing in China, Han Likang has a domestic sales of 2.

In addition, according to incomplete statistics, in addition to the above two, there are currently 13 domestic pharmaceutical companies conducting clinical trials of rituximab-related drugs, and 7 are in clinical phase 3 or above, including two pharmaceutical companies.

It shows how serious the homogeneity competition of "rituximab" is, at least in terms of the drug's research and development and market promotion, the gap is not small compared with neighboring countries, and the eyes of domestic players are mostly focused on the domestic market, as for the overseas market.

However, at least the first step in the replacement of the "rituximab" market, Fosun Pharma’s Han Likang has made a good start.

In general, the one that has the most strength to compete with Roche’s original research drug Rituxan and has the most opportunity to achieve overseas market expansion is undoubtedly Fosun Pharma’s Han Likang.

Picture source: Qianyan Industry Research Institute

Looking back at Han Likang’s overseas layout, as early as December 2019, Henlius (a subsidiary of Fosun Pharma) signed an exclusive license agreement with Colombian pharmaceutical company FARMA DE COLOMBIA, granting it to target companies in Colombia, Peru, Ecuador and Venezuela Exclusive license and commercialization rights for the first self-developed product HLX01 (rituximab)

Perhaps the choice of Colombia, Peru, Ecuador, and Latin America for overseas layout is considered by most to be of little significance, but this is also the helpless move of Fosun Pharma forced by South Korea’s Truxima to predictably deploy the US market as early as 2017.

According to the data, Han Likang is also a biosimilar of the original drug Rituxan.

Among them, the multicenter, randomized, double-blind, head-to-head and original research comparative clinical trial results of phase 3 treatment of diffuse large B-cell lymphoma also showed that the 6-cycle best overall response rate of Hanlikang and the original drug combined with CHOP was 92.

In addition, Fosun Pharma has also carried out a clinical study of rituximab for rheumatoid arthritis indications that have not yet been approved in China.

Image source: Fosun Pharma Announcement

In May 2021, Han Likang's 500mg/50ml specification will be launched and supplied.

With Fosun Pharma's (Fuhong Henlius)'s series of production and new indications in Han Likang, in the future, domestic rituximab is likely to gradually radiate from Latin America and other places to the world, like Truxima in South Korea.

Reference

http:// Pharma official website