According to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, less than two percent of Americans use biologics, but they account for 40 percent of total spending on prescription drugs.
Biosimilars are essentially generic versions of biologic drugs. But unlike traditional generic drugs, they are not direct copycats of the branded drugs they are designed to compete with. They are, in fact, “similar.” As a result, biosimilars must go through a regulatory approval process much like their branded drugs do. The subtle differences are apparently being used by marketers, biopharma companies and industry-funded advocacy groups to fend off competition by sowing doubts about the safety or effectiveness of biosimilars.
According to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, less than two percent of Americans use biologics, but they account for 40 percent of total spending on prescription drugs. They also represent 70 percent of the growth in drug spending from 2010 to 2015 and are expected to be the fastest growing segment of drug spending.
As a result, the FDA and U.S. insurers have made it a priority to cut the costs of biologics and increase their access in the U.S. The FDA implemented a Biosimilars Action Plan in mid-2018 to help make that happen. Not surprisingly, biopharma companies aren’t overly enthused about generic competition for their most expensive and profitable drugs.
U.S. approval and adoption of biosimilars lags significantly behind that of Europe. According to The Washington Post, more than 40 biologics have been approved in Europe, but only 16 have been approved in the U.S. And of those approved in the U.S., only a handful are actually being marketed or adopted, often because of delaying business tactics by the companies that manufacture the biologics being copied.
But another way they are fighting biosimilars is something of a propaganda campaign to create concern about their safety and effectiveness among physicians and patients.
“This is a field in which the marketers are having a field day,” Corey Cutler, an oncologist at Dana-Farber Cancer Institute in Boston, told The Washington Post. He noted that because of the complexity of the biologics and biosimilars, as well as the regulatory pathway, it is difficult for the FDA and the biosimilar manufacturers to convince the public the biosimilars are safe. “It’s just hard to understand,” he said.
The FDA assures the public that biosimilars are as safe and effective as the branded versions, stating there are “no clinically meaningful differences in safety, purity, and potency.”
But companies and advocacy groups often funded by industry cite the potential for problems. The Post notes, “The campaign of confusing, mixed messages has been underway for years but is attracting greater attention as market competition edges closer to reality.”
The Washington Post identifies the Biotechnology Innovation Organization (BIO), Amgen and Roche’s Genentech as financial backers and prime “member partners” of the nonprofit Alliance for Safe Biologic Medicines, which is part of a network of industry-funded groups working to slow biosimilar competition.
Philip Schneider, chairman of the alliance’s international advisory board and former associate dean of pharmacy at the University of Arizona, told The Post that the U.S. medical committee should move with caution when moving patients to unbranded biologics “so we don’t end up with another thalidomide” or “all the other things that happen when safety isn’t considered.”
That’s quite a negative connection and a very broad statement. It also happened 60 years ago. Thalidomide was marketed to pregnant women in the 1950s and 1960s and led to deformities in children. The Post writes, “Warnings about hazards also are contained on the Alliance for Safe Biologic Medicines website. In a video posted on the site, Schneider declares briefly that generic versions of biotech drugs are ‘safe and effective’ but goes on to say, with much greater emphasis: ‘They may or may not produce the same effects, or they may carry additional risks.’”
Another example is a patient advocate affiliated with the Alliance, Kathleen Arntsen, who has spoken out about how changing from a brand name biologic to a biosimilar could disrupt “continuity of care” and lead to emergency room visits “or being hospitalized.” When The Post interviewed her, she said she based that statement on her own experience from 20 years ago when she was changed from one anti-malarial drug to another. She denied that her statements were intended to throw doubt on the safety of biosimilars.
Meanwhile, biopharma companies are squaring off against each other and facing questioning from Congress over anti-competitive practices. Johnson & Johnson is in legal battles with Pfizer over rebates for its biologic Remicade, and AbbVie is being questioned by Congress about how it is fending off competition for Humira. And in August, Pfizer sent a petition to the FDA accusing Amgen, Genentech and Johnson & Johnson’s Janssen Biotech of misleading physicians and patients.
And with the 2020 U.S. Presidential election already starting, with Massachusetts Senator Elizabeth Warren(D) throwing her hat in the ring shortly after introducing a bill that would allow the federal government to take over generic drug manufacturing, the fight over drug pricing and generic and biosimilar access is only likely to become hotter.
