“It’s one thing for us to get the biosimilar approved and go through all of that,” said Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer. “That was the early conversation of the market developing. Now the market needs to be accessible.”
So far, 2018 has been a notable for Pfizer’s biosimilar ambitions, with the FDA having approved 2 supportive care biosimilars—a filgrastim and an epoetin alfa—already this year, bringing the company’s total number of US-licensed biosimilars to 4.
In an interview with The Center for Biosimilars®, John P. Kennedy, general manager of US Biosimilars for Pfizer Essential Health, said of these new approvals, “We’re excited that we are building a robust portfolio that is in line with our intent, which is to be a significant and leading player in the biosimilars space more broadly.”
But while Pfizer has been making strides forward on the regulatory front, uptake of its 1 commercially launched US biosimilar, Inflectra, has remained disappointingly low, even though Inflectra’s average sales price (ASP)—$602.30 for 100 mg—is currently 24% lower than Remicade’s ASP of $792.50 for 100 mg, according to data provided by Pfizer.
Despite the potential savings posed by the lower-price biosimilar, according to data from Avalere, just 2% of patients with commercial coverage can freely access Inflectra as the first step in their biologic therapy. And while a recent case study from The Pacific Research Institute indicated that if biosimilars of infliximab were to reach 50% market annual cost reductions for patients with employer-based coverage could be as high as 8.4%, and for patients covered by Medicare, as high as 8.1%, uptake remains slow.
Kennedy said that while the company is “seeing some traction in the Medicare space, where value is more appreciated,” and is “making inroads in terms of increased coverage among some commercial payers,” challenges linger for Inflectra in the face of what it has called anticompetitive conduct on the part of Remicade’s sponsor, Johnson & Johnson (J&J).
In 2017, Pfizer filed a lawsuit against J&J, saying that the company threatened to withhold rebates from insurers unless they agreed to exclude biosimilars from their formularies. The case is currently awaiting a ruling, and, according to Pfizer, very little has changed in the market during the intervening year.
Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer, added that, as evidenced by the FDA’s newly unveiled Biosimilar Action Plan, “There’s a growing sense of concern with the administration that the barriers that are in front of biosimilar uptake will continue and that the market won’t form or be substantial. J&J's exclusionary contracts are definitely part of that.”
To Reed, the FDA’s plan represents an encouraging step forward; while she noted that Pfizer looks forward to the emergence of further detail, she feels that the document addresses most of the items on which the company has been awaiting greater clarity.
Reed also sees the FDA’s signals that it intends to partner more closely with the Federal Trade Commission (FTC) on addressing anticompetitive behavior as a positive. “It’s one thing for us to get the biosimilar approved and go through all of that,” she said. “That was the early conversation of the market developing. Now the market needs to be accessible.”
Greater regulatory alignment with the FTC has the potential to provide for just that, according to Reed, by addressing anticompetitive practices in a variety of forms, including addressing misinformation—or what Reed termed “fear-mongering”—about biosimilar safety; while the FDA can provide education about biosimilars, the FTC may have the authority to address inaccurate materials in the public space that have a chilling impact on competition.
Those steps forward could provide a key to ensuring the future of the biosimilars market in the United States. According to Pfizer, if behavior in the market does not change, neither will patterns of uptake and cost savings.