Confirmation that 2015 will be a watershed year for biosimilars came with data on Remsima presented at the European Crohn’s  and Colitis Organisation meeting held in Barcelona.
 
Remsima – Celltrion’s biosimilar of Johnson & Johnson and Merck & Co's anti-inflammatory blockbuster Remicade (infliximab) – is the world’s first biosimilar monoclonal antibody to come to market.
 
New data support Remsima as an effective and well-tolerated  treatment option for patients with Crohn’s and UC. The data (from six prospective observational trials involving 258 patients from Europe and South Korea) is seen as important.  The safety and efficacy of biosimilar infliximab has been demonstrated by pivotal trials in rheumatoid arthritis and ankylosing spondylitis and is already approved in Europe for eight autoimmune diseases, including Crohn’s and UC. 

Approval for these bowel diseases was based on extrapolation of clinical data in rheumatologic diseases, however some regulators and clinicians have asked for specific data on use in bowel disease.
 
The roll out of biosimilars has been predicted to create billions in health care savings and transform the industry landscape.  The potential for savings was underscored by other Remsima data presented at ECCO.
 
A budget impact analysis by Mundipharma predicts that using Remsima in treatment-naive and switch patients with Crohn’s and UC could save between 17 and  51 million euros per annum across Germany, the UK, Italy, the Netherlands and Belgium. This could allow almost 5,000 more patients with inflammatory bowel disease to receive biologic therapy.
 
A Celltrion budget impact analysis calculates five-year costs savings across the UK, Italy and France ranging from 76 million to 336 million euros, so little wonder that biosimilars are attracting interest from healthcare purchasers.

First-line treatment in Norway
 
In Norway, a country with a nationwide annual tender system for biologics, Remsima has been in use for just over a year. The biosimilar significantly undercut Remicade in tendering and immediately became first line treatment when starting biologic therapy in new IBD patients, said Professor Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway.
 
He added that experience to date is that the efficacy and safety of Remsima in the treatment of IBD appears similar to Remicade when treating new patients. The Norwegian government is now funding the Nor-Switch Study to evaluate the interchangeability of Remsima and Remicade in existing IBD patients. Data from this study are expected in 2016.
 
“The cost of the biosimilar means that I can treat a patient for three years with Remsima versus one year with Remicade,”  said Prof Jahnsen. He believes that hospitals will start switching some IBD patients this summer, well before the Nor-Switch results become available.
 
A raft of exclusive and co-exclusive marketing agreements govern the global sales of Remsima. In addition to being marketed by Celltrion, Mundipharma and its independent associated companies has exclusive rights to market Remsima in the UK, Germany, Italy, Belgium, Luxembourg and the Netherlands. Hospira has also licensed the biosimilar from Celltrion and will sell it branded as Inflectra in Europe and other markets, including the USA and Canada.
 
Also at ECCO, Pfizer presented data on PF-06438179, their candidate infliximab biosimilar. The Phase I data support a similar structural and functional profile to infliximab. A global comparative phase III clinical trial (NCT02222493) comparing PF-06438179 and infliximab in rheumatoid arthritis is underway and is slated to report in 2017, said a Pfizer spokesman. The US giant recently agreed to purchase Hospira, sending a strong signal to investors that biosimilars are here to stay.
 
In the USA, Food and Drug Administration advisors will meet next month to review Remsima – the first monoclonal antibody to use the agency’s new biosimilar pathway.