Category Archives: Biosimilars

Biogeneric infliximab now available in Europe

 

 

Hospira, Inc. logo

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.

 

Biocon Mylan Biogenerics Partnership

Today we learn that generics giant Mylan has entered into a partnership with India-based Biocon to focus on insulin analog biosimilars:

Under the terms of this collaboration, Mylan will have the rights to develop and market Biocon’s Glargine (the generic version of Sanofi’s Lantus®), Lispro (the generic version of Eli Lilly’s Humalog®) and Aspart (the generic version of Novo Nordisk’s NovoLog®).

Mylan and Biocon will share development, capital and certain other costs to bring the products to market. Mylan will have exclusive commercialization rights in the U.S., Canada, Australia, New Zealand, the European Union and the European Free Trade Association countries through a profit share arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in certain other markets around the world.

This is consistent with one of the panel discussions at BioEurope in November, in which Amgen and other major biotech companies said that very few companies will succeed in the biosimilars space, at least in the near term. The most successful companies will need the large-scale access to cell lines, manufacturing, marketing, and distribution assets which are unique to biologics, and quite different from your traditional oral/parenteral products.