US sales of Janssen’s biologic Remicade for the first six months of 2016 grew 14% year-on-year to $2.4bn, but export sales to its distribution partners saw another period of decline “due to the impact of biosimilars,” management said in a conference call last week.
But with the regulatory approval of Inflectra earlier this year, the drug could be facing biosimilar competition later this year if Pfizer/Celltrion is successful in upcoming legal battles with the Johnson & Johnson subsidiary.
Already in some European markets biosimilar discounts and switching have heavily impacted Remicade’s presence, and with J&J’s preference to keep its complex mAb in-house we asked the firm whether it is considering restructuring its Remicade production network or using third-party manufacturers to manage potentially reduced volumes of the mAb.
“The various stages of Remicade production occur at Janssen manufacturing sites located in Leiden, The Netherlands, Malvern, Pennsylvania (US), and Schaffhausen, Switzerland,” a spokesperson from the firm told Biopharma-Reporter.com.
“There are no plans to make changes to the network of facilities responsible for manufacturing Remicade.”
180 days’ notice
Pfizer is expected to launch Inflectra in the US around October 6 this year, following the landmark US Court of Appeals for the Federal Circuit ruling earlier this month that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice from the date of FDA approval before commercial marketing of a biosimilar can begin (see this article from RAPS for more details).
However, J&J remains confident there will be no biosimilar launch this year and has not factored any US erosion into its 2016 guidance.
“There are ongoing developments in the litigation,” CFO Dominic Caruso said in last week’s conference call (transcript here). “There's a hearing scheduled for August related to the 471 patents. We'll have to see what the results of that hearing are, so we don't know that yet.”
Furthermore, CEO Alex Gorsky told investors on the call that there will still be demand for Remicade once a copycat version is launched:
“We know that there are about 2.4m patients who've been treated with the compound. We know that about 70% of them in fact are getting good relief and good effects. We know that they're unlikely to be switched when they're getting a positive response from the therapy.”