Earlier this month, the US Food and Drug Administration (FDA) approved its first monoclonal antibody biosimilars, Remsima and Inflectra, copies of J&J subsidiary Janssen’s Remicade (infliximab).
Inflectra’s marketing authorisation holder Pfizer had been prepping for a launch later this year, but during a conference call discussing first quarter results yesterday, J&J said it will not see US biosimilar competition in 2016 and will fight to retain exclusivity beyond this.
“Our assumption with regard to Remicade biosimilar remains unchanged, even with the recent FDA approval of Inflectra, due to our intellectual property [IP], which we intend to defend,” CFO Dominic Caruso told stakeholders.
This includes US patent number 6,284,471 (“the ‘471 patent”) relating to the method of action of anti-human tumor necrosis factor-alpha (hTNFα) antibodies which expires in September 2018, and a patent surrounding the culture media used to produce infliximab (US patent 7,598,083, or ‘083) which expires in 2027.
However, Caruso said Celltrion – the maker of Inflectra and Remsima – has issued Janssen with the mandatory 180-day notice period setting a commercial launch of its biosimilar around October 2.
Janssen has already taken action to block this, urging a Massachusetts federal judge to initiate a patent trial to block the launch based on “powerful evidence that the defendants’ cell culture media infringe the ‘083 patent.”
Launch and discount
But Pfizer remains confident Inflectra will enter the market later this year.
“While launch timing will ultimately depend on a number of factors, we are moving ahead with the preparation of our launch plans for 2016,” a spokesman told Biopharma-Reporter.com. “We cannot comment on the potential reaction or response of other companies.”
For the first quarter 2016, Janssen’s Remicade sales in the US grew almost 15% year-on-year to $1.2bn. Outside the US where biosimilars have already entered the market, sales dropped 8% for the quarter to $335m.
The only biosimilar currently available in the US is Sandoz’s Zarxio, launched last September at a 15% reduction to Amgen’s reference product Neupogen (filgrastim).
While Pfizer did not reveal at what discount to Remicade Inflectra could be launched at, we were told: “The overall cost savings and generally positive reception of Inflectra in other markets to date is consistent with our belief that biosimilars can be an important and a welcome option for patients, prescribers and payers.”