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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Remsima will now be available for patients in 12 additional countries in the European Union.
Known as the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA), Celltrion’s Remsima (infliximab) was launched on Feb. 24, 2015 in Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden, and the United Kingdom. The European Commission approved Remsima in September 2013.
Both Remsima and Inflectra are developed and manufactured by Celltrion. Interestingly, Celltrion is launching Remsima in many of the European countries in which its co-exclusive partner, Hospira, has approval of Inflectra (infliximab), meaning biosimilars of the same product will be available in Europe and could possibly compete with one another. According to BioCentury, Hospira and Celltrion amended their 2009 agreement, giving Hospira exclusive rights to market its biosimilar in the United States, Canada, and “other undisclosed territories.” Inflectra is currently approved in 24 European countries.
The partners will use multiple brand names, or a two-brand strategy, to market the product in different geographic regions. “A two-brand strategy for the same product is not uncommon in the industry,” a Celltrion spokesperson told BioPharm International. “Due to marketing matters including cultural differences and different distributors in local markets, pharmaceutical companies use multiple brand names catering to local needs. Hospira, in partnership with Celltrion Healthcare, uses its own brand name, Inflectra, in their territories, while other partners use Remsima.”
The news of the launch comes on the heels of new data presented at the European Crohn’s and Colitis Organization’s 10th annual congress in Barcelona showing that Remsima was an effective and safe treatment option for Crohn’s disease and ulcerative colitis. Although approval for these indications was based on extrapolation of indications for Remicade, the data from six new observational trials confirm Remisima is a well-tolerated option for these bowel ailments.
According to a Celltrion budget impact analysis presented at the meeting, five-year cost savings across the UK, France, and Italy associated with using Remsima instead of branded anti-tumor necrosis factor mAbs could range from 76–336 million euros. A Celltrion press release noted that biosimilars are projected to save health systems in Europe 11.8–33.4 billion euros between 2007 and 2020, while biosimilar mAbs are expected to deliver the greatest savings, ranging from 1.8–20.4 billion euros. Biosimilars are thought to produce the biggest savings in France, Germany, and the UK, according to the statement.