Janssen’s parent company Johnson & Johnson reported its third quarter 2014 financials this week with total sales across all its divisions of $18.5bn (€15bn), up 5% year-on-year.
The firm’s topseller was Remicade (infliximab), a monoclonal antibody drug to treat rheumatoid arthritis, which saw a 7% rise in sales to $1.1bn compared to Q3 2014 pushing total sales this year past the $3bn mark.
The increase is somthing of a suprise given that, over the past eighteen months, a number of companies have been looking to take on Janssen with biosimilar versions of Remicade. In Europe, the EMA approved Celltion’s Remsima and Hospira’s Inflectra last year, while Epirus is also looking to enter Europe with its Remicade biosimilar, as well as targeting the Indian market.
J&J’s CFO Dominic Caruso remained confident about the strength of Remicade and its IP protection during a conference call this week, though said 2015 would be a significant year for Remicade in the EC as the drug’s patent expires (Celltrion’s Inflectra has already been launched in Central and Eastern Europe).
“[Outside the US] we haven't seen much of an impact, and we know that that even pricing is sort of in the 30% range down from the branded product,” he told investors (transcript here), adding he expects little impact for Remicade too.
Janssen’s anaemia drug Procrit (epoetin alfa) is already subject to biosimilar competition in Europe but Caruso said the firm has not seen “much of an impact” in Europe. Sales of the drug worldwide have been on a steady decline over the past ten years according to annual reports, from $4bn in 2003 to $1.4bn last year, though figures are not split by geography.
US Patent
However, it is in the US where the advent of biosimilars could raise more of a concern. The last few months saw both the US FDA agree to review Sandoz’s version of Amgen’s Neupogen, Zarzio, indicating biosimilars could infiltrate the US market in the near future, and a successful Celltrion challenge to Remicade’s 2018 patent.
In July, the United States District Court of Massachusetts dismissed Janssen's attempts to protect Remicade's protection to 2018 by asserting patent rights and denying license requests from Celltrion.
“It's true that the Patent Office recently issued a rejection to that patent,” Caruso said, “but we have recently filed a revised amendment to that… and we don’t expect that there will be a final adjudication of the patent for several years now.
“Whether or not the biosimilar comes to market in the face of that particular patent situation is up to the competitor. But we certainly continue to believe in the strength of our patents and the validity of those patents and we’re in active discussions with the Patent Office and will pursue all available appeals and all the available avenues of jurisdiction that we have to us.”