Several biosimilar versions of Janssen and Merck & Co’s blockbuster auto-inflammatory drug Remicade have hit all the major European countries as the generic companies behind them look to take a bite out of the $2bn market for the drug.
Remicade currently has a number of licences in the EU for diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis and arthritis psoriasis.
The treatment has been a massive earner for Janssen and its partner for the medicine Merck & Co (which sells the drug in Europe), bringing in more than $8.5bn last year, making it one of the biggest selling treatments on the planet. Around $2bn a year is spent on the drug across Europe.
But its patents across much of Europe have now expired. Hospira, which was recently bought by Pfizer for around $15bn, has now launched its biosimilar Inflectra (infliximab) in the UK and other key EU states, while rival Mundipharma has launched its own version under the name Remsima.
Remsima will now be available in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg, while Hospira is to sell Inflectra in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden.
Versions of Remicade have been on sale for several months in some smaller European markets, but this new move into major economies is a big step forward for the biosimilars.
Andrew Baum, an analyst at Citigroup, has predicted that biosimilars will result in at least $110bn of value being transferred from innovator companies to biosimilar producers between 2015 and 2025, generating $50bn in savings for health systems.
Hospira’s partner, the South Korean firm Celltrion, has also submitted an application to the FDA for a biosimilar version of infliximab, although the path to approval there may prove much more difficult as the US regulator lags behind the EMA when it comes to assessing biosimilars.
Nevertheless, Pfizer will not have to wait long for a preliminary decision on its infliximab biosimlar as an advisory committee is set to decide on March 17 whether to recommend Celltrion’s version of Remicade.