The launch of a Remicade biosimilar from Johnson & Johnson (NYSE:JNJ) in the U.S. is likely to come to a halt if the threat by Incheon-based Celltrion is anything to go by. Claims by the South Korea firm that it had won a U.S. FDA nod for a biosimilar of Remicade were downplayed by vice president of investor relations, Louise Mehrotra and chief financial officer, Dominic Caruso. The duo fielded many questions on the approval.
However, Caruso did confirm that a 180-day notice period that follows such approval had been received from Celltrion but there are chances that the party would carry on. He said that the assumption regarding Remicade biosimilar remains unchanged despite the recent FDA’s approval of Inflectra which Caruso says they intend to defend due to their intellectual property.
But Josh Jennings, an analyst with Cowen and Company still wanted to know Caruso’s position on the view that no Remicade biosimilar will get access to the U.S. market in 2016. Caruso explained in details that they are ready to defend their several patents. The 471 patents alone extend to 2018 while another is all the way to 2027. Besides, the company is not foreseeing any biosimilar competition in 2016.
Mehrotra echoed Caruso’s sentiments citing the global resilience of growth figures for Remicade. There is a lot to show. For example, Combined Remicade export sales and international sales gained an 11% growth. International direct market sales were up approximately 17% as a result of the primary strong double-digit development in the western hemisphere. The double-digit development, however, excluded the US.
Caruso was quick to give an update on China’s slowdown in the fourth quarter of 2015 whereby he explained that it takes about 5% of the overall business. The explanation sounds more or less like what was stated in January.
He talked of a slowdown in the economy which may have led to the relatively high levels of distributor inventory which again is slowly coming down.