Tony Hagen is senior managing editor for The Center for Biosimilars®.
Defining biosimilar use in the United States as "sluggish," Juliana Reed, MS, said employers have to get involved.
The top 10 biologics by revenue have all been on the market more than 17 years, and each has amassed cumulative sales of more than $40 billion since launch. Those include adalimumab (Humira, $112 billion), epoetin alpha (Epogen, $97 billion), and etanercept (Enbrel, $80 billion). However, biosimilars for these drugs have yet to achieve more than a toehold in the US marketplace, and for employers, this represents a huge missed opportunity, according to Juliana Reed, MS, a vice president and Global Corporate Affairs lead for Pfizer.
“The big story is the low uptake of biosimilars in the United States. Cost savings is being left on the table,” she said in an employer issues webinar held this week hosted by the Pacific Business Group on Health and the Integrated Benefits Institute.
Reed noted that although 60% of overall biologic medicine sales occur in the United States, 90% of biosimilar sales occur in Europe, and she urged US employers to get involved and start advocating for greater use of biosimilars.
Getting Hold of the Savings
In the United States market, the “lost savings” amounts to $20.4 billion from 2018 to 2020, she said. “This is not just for Medicare. This is across the marketplace.”
“It’s going to take proactive work on your part,” she told employers, to funnel biosimilars into the health care stream and wrest some of those billions away from the dominant originator brands.
These unrealized savings could have reduced patients’ out-of-pocket expenses by $167.5 million in 2020, she said. “It’s something to think about especially considering that we are looking at recessionary conditions and negative economic impact from [the pandemic].”
Former FDA Commissioner Scott Gottlieb, MD, was a champion of biosimilars, and that momentum has not been lost with his departure, she said. There is support from the current administration and both sides of the aisle in Congress to move forward on driving down pharmaceutical costs. This is really about supporting the sustainability of the market, supporting the uptake, supporting the [biosimilar] competition so that we can drive lower cost,” she said.
There are lessons that can be learned from the market for generics, which received a big boost from the Hatch-Waxman Act of 1984. Provisions of that legislation spurred the development of generics while preserving incentives for innovator companies to develop new products. Hatch-Waxman kept the United States in the forefront of drug innovation but also enabled tremendous savings. Ninety percent of prescriptions filled in the United States are generics, and 95.3% of generic prescriptions are filled for $20 or less, Reed said, and that amounts to hundreds of billions in savings each year.
“What type of lessons could be applied in the biosimilars marketplace that could help grow the marketplace but also see success and continued sustainability of biosimilars?” Reed asked. One way is to incentivize biosimilar uptake, and that can be done by introducing policies that cut patient out-of-pocket costs, share savings with providers who prescribe biosimilars, and increase the average sales price add-on paid to physicians for biosimilar purchases.
A piece of legislation she said that would accomplish the add-on increase is S-2543, the Prescription Drug Pricing Reduction Act.
Another bill, S-1895, the Lower Health Care Costs Act, would target anticompetitive practices that biosimilar advocates say are rampant and that cause patients and providers to lose confidence in the safety and efficacy of biosimilars, although FDA approvals carry the assurance that biosimilars are as safe and efficacious as originator drugs.
“We know we have to address anticompetitive behaviors that disincentivize the uptake of biosimilars, but we also need proactive policies that incentivize the uptake of biosimilars," Reed said.
She added that anticompetitive practices may include deliberately disparaging statements and misinformation that sows confusion and doubt about these products. Other factors that impede biosimilar uptake and that need to be addressed include:
“Biologics right now represent the majority of the medicine marketplace here in the United States but also the majority of the spend,” which is why it’s important to focus on the opportunity available in biosimilars to reduce cost, Reed said.
Pfizer has made a commitment to the biosimilar space and during the first quarter of 2020 was among the leaders in putting products onto market.