Celltrion, the sponsor of a biosimilar of Roche’s rituximab (MabThera/Rituxan) approved in the European Union (EU), received approval from the EU’s Committee for Medicinal Products for Human Use (CHMP) to market the drug under 3 more names: Tuxella, Ritemvia, and Blitzima. Celltrion’s rituximab is already marketed in Germany under the name Truxima. Marketing authorizations for some of the names are slightly different; for example, Ritemvia has an indication for chronic lymphocytic leukemia, whereas Blitzima and Tuxella do not have that indication.
The European Commission will decide whether to approve the CHMP’s decision in a few weeks. Truxima is the first Rituxan biosimilar approved by the European Medicines Agency (EMA) and the first biosimilar to be approved for a cancer indication. Truxima’s label indicates it can be used for the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, in addition to autoimmune disorders.
The action to secure additional names for Truxima generated surprise among some market experts and commentators, and drove speculation about Celltrion’s strategy, which may revolve around generating more total market share through multiple names for the product. Several years ago, Celltrion gained 2 marketing authorizations for its biosimilar to Merck’s infliximab (Remicade) and later sold one of them to Hospira. Celltrion marketed its own product as Remsima, and Hospira marketed its drug as Inflectra. In some markets the competition resulted in biosimilar rituximab selling at a 70% discount to the branded Remicade, eliminating the brand from some Nordic markets where prices were at their lowest.
In the case of its biosimilar rituximab, Celltrion may be setting up the company to have more choices and potentially giving itself the opportunity to give out rights to several different companies, who would compete against each other and maximize market share for Celltrion head of biosimilar rivals. Sandoz recently received a recommendation for approval from the CHMP to market its biosimilar rituximab, creating a likely rival drug launch for rituximab in only a few weeks.
South Korea—based Celltrion has indicated it may apply for FDA approval for rituximab by June 2017. If approved, it would be marketed in the United States by Celltrion’s US commercial partner, Teva Pharmaceuticals.
Rituxan is the world’s second top-selling drug, with sales of more than $7 billion in 2016.