In recent months, South Korean biosimilars firm Celltrion has announced a series of successes, including winning a patent case against Samsung Biogen and expansions in the European and Latin American markets.
Rituxan (rituximab) is marketed by Samsung Biogen and used to treat autoimmune disorders and types of cancer, in particular leukaemia. Celltrion’s biosimilar version (Truxima) won US Food and Drug Administration (FDA) approval back in November 2018 [1], making it the first biosimilar to be approved for the treatment of non-Hodgkin’s lymphoma. However, the company has until now not been able to market the drug domestically.
The Patent Court of Korea recently upheld the judgement of an IP tribunal, which invalidates Samsung Biogen’s patent on Rituxan and allows Celltrion to market biosimilars of the drug in South Korea. The company has filed five lawsuits seeking the invalidation of Samsung’s patents, the previous four of which also ruled in Celltrion’s favour.
Truxima is already licensed in Europe and the company recently announced that the drug claimed 35% of the market share in Europe. In the UK, it reached a huge 66% market share, and 42% in France.
Since launching in Europe, Truxima has grown at a pace three to four times that of Celltrion’s Remicade biosimilar, Remsima, which reached 11% market share in the second year of its launch.
The company has also launched Herzuma, a biosimilar of Herceptin (trastuzumab) [2], which has already gained a 6% market share in Europe. The company won a patent suit on the drug in Japan in 2018, invalidating Roche’s patent in the country [3].
In other corners of the world, Celltrion has won bids to supply Truxima to Latin America. They will exclusively supply rituximab to Ecuador in the next two years. The company now has sales licenses for Truxima in seven Latin American countries and expects to soon receive approval to market the drug in Brazil, Chile and Peru.
Celltrion already sells its infliximab biosimilar Remsima in Peru, which has dominated the market (taking 95% of the share), and plan to launch Herzuma in Brazil and Mexico.
A company official said: ‘In most Latin American countries, which have a principle of free supply of medicines, their governments have a high preference for medicines that can save health insurance money. As a result, the preference for biosimilars with high medical efficacy, safety and price competitiveness is increasing’.
Looking ahead, these expansions will help the company to launch Truxima in the US. ‘All three major biosimilars of Celltrion are recognized in the medically advanced Europe and are steadily expanding their markets. We will do our best to succeed in the US market for Truxima based on our success in Europe’, said a Celltrion official.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Herzuma
3. GaBI Online - Generics and Biosimilars Initiative. Celltrion wins patent suit in Japan over trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/General/Celltrion-wins-patent-suit-in-Japan-over-trastuzumab-biosimilar
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