Today we learn that a biogeneric form of Remicade, the first biogeneric monoclonal antibody, will shortly be available in Europe:
Tuesday’s final green light for Inflectra – which was developed by South Korea’s Celltrion and will be marketed by U.S. company Hospira – had been expected following a European Medicines Agency recommendation in June.
Hospira said the drug for treating rheumatoid arthritis and some other conditions would be launched throughout Europe “at the earliest opportunity taking into account any relevant patent protection”.
European sales of branded Remicade were over $2 billion in 2012.
Branded as Inflectra, infliximab was approved on the backs of extensive clinical studies versus branded Remicade:
Inflectra was approved by the EC following review of safety, efficacy and tolerability data from a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In the study, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment (measured using the ACR20 scoring system), compared with 69.7% treated with Remicade. Safety and tolerability data also demonstrated Inflectra’s equivalence to Remicade.
We don’t know what the pricing will be, but consensus seems to be at a 25%-35% discount relative to Remicade.