South Korean biopharma company Celltrion is on track to commercialize a Rituxan biosimilar for the first time in Europe early next year, marking another major milestone for the drugmaker.

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive recommendation of Celltrion’s Truxima, a biosimilar referencing the blockbuster lymphatic cancer drug Rituxan (rituximab) on Friday.

In line with the CMPH’s recommendation, the EMA is expected to officially grant Truxima marketing and sales approval effective in 31 European countries, as early as February next year, Celltrion said.


Truxima is Celltrion’s second biosimilar to be commercialized in Europe. The Korean drugmaker began selling its Remicade biosimilar in Europe in February 2015 and in the US from November this year.

Biosimilars refer to cheaper, near-replicas of biologic drugs which have lost patent protection. Multiple companies around the world have been developing biosimilars in line with the approaching patent expiry of some of the world’s top-selling biologics.

Rituxan, also sold under the name Mabthera, was originally developed by Biogen and is sold globally by US pharmaceutical giant Roche. As of last year, Rituxan was the world’s second best-selling biologic drug, having generated worldwide sales of $7.3 billion in 2015.

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

In addition to Remsima and Truxima, Celltrion has filed another biosimilar drug called Herzuma -- referencing Roche’s Herceptin -- for approval by the EMA. The Korean drugmaker plans to seek the US FDA’s approval for Herzuma as well.

Celltrion holds high expectations for its three biosimilar drugs -- all of which are or will become the first biosimilar versions of their respective originator drugs to enter major markets.

“Together, the three originator drugs targeted by our biosimilars account for a global market worth around 25 trillion won ($21.5 billion),” Celltrion said in a statement.

“By selling our products at 30-40 percent discounted prices, we can target a market worth at least 15-17 trillion won. And taking away just 20 percent of this market will amount to sales of more than 3 trillion won within 2-3 years,” it said.

As of June 2016, Celltrion’s first biosimilar referencing Remicade -- commercialized in Europe under the name Remsima in February 2015 -- had taken away some 40 percent of the originator drug’s sales in the region, the company said.

Remsima is expected to generate additional sales in the US, where the biosimilar is sold under the Inflectra name through Celltrion’s US partner Pfizer. Celltrion Healthcare, the distribution unit of Cellrion, has stated that it will ship some 260 billion won worth of the drug to the US by the end of the year.

“Like the stellar performance shown by Remsima, we expect Truxima to follow a similar sales trajectory across European markets,” Celltrion said.

By Sohn Ji-young (jys@heraldcorp.com)