South Korea’s Celltrion announced Wednesday that the European Medicines Agency has granted sales approval to Truxima, its biosimilar drug referencing Roche’s blockbuster lymphatic cancer drug Rituxan.

Truxima is the first ever Rituxan (rituximab) biosimilar to be approved by the European drug regulator, as well as the first ever Europe-approved biosimilar monoclonal antibody used to target cancer.

Biosimilars are cheaper, near replicas of living cell-based biologic drugs whose patents have expired. The recent emergence of these alternative drugs have begun to threaten the exclusivity of some of the world’s top selling pharmaceuticals, held by a handful of global pharma giants.


The EMA has approved Truxima for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

With the approval, Truxima can now be sold at 28 European Union member states including the UK, Germany, Italy, France and Spain as well as Norway, Iceland and Lichtenstein.

Celltrion said it would continue to work with its marketing partners for Europe -- including Mundipharma, Biogaran and Kern Pharma -- to begin selling Truxima across Europe from the second quarter, starting with the UK.

“We expect Truxima to secure a strong competitive edge in the global market for monoclonal antibody drugs as it faces no competitors other than the original drug Rituxan,” Celltrion said in a statement.

Truxima is likely to be the only Rituxan biosimilar in the market for the time being, though competing drugs are on their way.

Novartis-owned Sandoz submitted its own biosimilar referencing Rituxan to the EMA for approval in May 2016, while Pfizer and Amgen are wrapping up third-phase clinical trials of their own Rituxan biosimilars.

Truxima is Celltrion’s second biosimilar to be commercialized in Europe. The Korean drugmaker began selling Remsima, its biosimilar referencing Remicade, in Europe in February 2015 and in the US (sold as Inflectra) from November 2016.

Rituxan, also sold as Mabthera, was originally developed by Biogen and is sold globally by US pharmaceutical giant Roche. It is the world’s second top-selling drug, having generated sales of more than $7 billion last year.

Celltrion plans to file Truxima for review by the US Food and Drug Administration by early next year as well, with hopes of becoming the first to introduce a Rituxan biosimilar in the US.

In addition to Remsima and Truxima, Celltrion is currently seeking the EMA’s approval of another biosimilar drug called Herzuma -- referencing Roche’s Herceptin. The Korean drugmaker plans to file the drug for approval by the US FDA 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.

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

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