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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.
Although Pfizer and Celltrion's Inflectra (infliximab-dyyb) was approved on April 5, 2016, Johnson & Johnson said in a second-quarter earnings call that the product will not threaten the sales of Remicade for the rest of 2016. J&J Chairman and CEO Alex Gorsky said during the call that this "assumption remains unchanged with the recent FDA approval of Inflectra." Pfizer says it still plans to launch Inflectra in 2016, even though a lab working with Celltrion is currently being sued by J&J’s Janssen unit for unlawfully using the same cell-culture media for Remicade biosimilars that it used for the production of Remicade.
Market size for Inflectra
Gorsky said that out of 2.4 million patients who've been treated with Remicade, "about 70% of them in fact are getting good relief and good effects" and that these patients are "unlikely to be switched when they're getting a positive response from the therapy." He also said that the size and strength of the Janssen and Johnson & Johnson portfolios will help the company secure Remicade as the therapy of choice with larger healthcare systems and networks.
This could mean that for 30% of the 2.4 million patients currently on Remicade, approximately 720,000 could feasibly be switched to Inflectra or another biosimilar to Remicade. In addition, new patients who are Remicade-naïve could be added to the patient population as eligible candidates for a biosimilar.
Dominic J. Caruso, executive vice-president and CFO of Johnson & Johnson, stressed that the waiting period for a biosimilar release for Remicade extends to October 6, 2016. He said that the outcome from an upcoming hearing on J&J's 471 patents covering Remicade this August will likely protect the brand for the remainder of 2016. Overseas, however, the company noted that the decline in Remicade export sales was due to the impact of biosimilars.
Source: Seeking Alpha