Pfizer and its partner Celltrion’s version of Remicade (infliximab) became the second biosimilar - and the first monoclonal antibody biosimilar – to be approved in the US earlier this year.
According to recent comments , Pfizer is looking to bring Inflectra to market as soon as possible, which could be as early as October 3 following a recent court ruling requires biosimilar applicants must provide at least 180-days’ notice to the reference product sponsor from the date of US FDA approval.
But speaking at the Wells Fargo Securities Research, Economics & Strategy 2016 Healthcare Conference last week, Johnson & Johnson CFO Dominic Caruso warned an early launch would be done at risk while patent disputes are still unsettled.
“We are not in a position to prevent their launch, but they know and we know that should they launch, they’re launching at-risk and it’s a calculation they would have to do,” he said.
Pfizer/Celltrion invalidated the ‘471 patent last month referring to Remicade’s method of action, but the courts have not yet ruled upon litigation surrounding the ‘083 patent which covers the cell culture medium used in the production of the reference mAb.
Caruso said his firm will not be undertaking a preliminary injunction ahead of the court’s ruling on the ‘083 patent which could, theoretically, restrain Pfizer from the October launch.
“That’s a patent not on the composition of matter of the molecule, but rather on the materials used to produce the product. So we didn’t believe a preliminary injunction was an appropriate way to go with that particular patent.”
J&J is, however, appealing the ‘471 patent decision, he added.
Pfizer and Celltrion’s biosimilars in Europe have been predicted to wipe-out Remicade through discounts and switching, and in some regions have already taken a market share approaching 80%.
But Caruso told delegates that even with an early launch, Inflectra will not have a big impact on adoption rates in the US.
“We don’t think that the adoption curve is that steep or therefore the erosion curve is that steep for a couple of reasons: 70% of the patients are adequately treated, there’s no interchangeability, and there’s sufficient price competition already in the marketplace,” he said.
“So the only real significant delta from one year to the next when we sort out these other comparables is the rate at which a biosimilar could penetrate the market - we don’t think it’s dramatic.”