J&J confident of retaining Remicade rewards as biosimilar clouds gather

In 2016, J&J reported historic revenue highs of $6.97bn for its autoimmune disease monoclonal antibody Remicade, reversing the 4.5% year-on-year drop in 2015 which had marred its continued growth since US approval in 1998.

The resilience came at a time when the drug remained unchallenged by biosimilar competition, but with the launch of Pfizer’s Inflectra at a 15% discount in November​ last year the firm has predicted a drop in sales for this year.

But despite the challenge from biosimilars, CFO Dominic Caruso told stakeholders at the 2017 UBS Global Healthcare Conference last week J&J expects its “number one product”​ Remicade to remain a top selling product for at least the next five years.

“We feel pretty confident that the impact of a biosimilar penetration will be gradual, not dramatic, and as we’ve seen so far, we have not actually seen much of an impact already with the biosimilar that was approved in November of last year,”​ he said.

“But as biosimilars become more common in the industry and there’s more than one biosimilar, I think it’s fair to say that that is something that I would call challenged. But nonetheless, we still expect Remicade to be a multi-billion dollar product over the next five years.”​

He also told investors J&J, through its subsidiary Janssen, was not reliant on the one molecule in immunology, having built “a fantastic franchise”​ through other biologics such as Simponi, Stelara, guselkumab and sirukumab, a monoclonal antibody filed for approval last year.

European infliximab​

In Europe, biosimilar versions of infliximab have been available since 2013 and Merck & Co. which holds marketing rights to Remicade in the region have seen a 30% drop in sales, Caruso said in January​, though in some countries sales of the reference product have effectively been wiped out​.

Inflectra and Remsima were the first to launch by Hospira (since acquired by Pfizer) and Celltrion, respectively, and in May 2016​ the EMA approved Samsung Bioepis’ infliximab, Flixabi, which is being marketed in Europe by Merck & Co.

And Novartis subsidiary Sandoz is also looking to take a share of the European market, announcing today a Marketing Authorization Application for its infliximab biosimilar – along with a biosimilar of AbbVie’s Humira (adalimumab) – has been accepted for review by the EMA.

“The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline,”​ Mark Levick, Sandoz’s global head of biopharmaceutical development said in a statement.