Uptake of Biosimilars in the US: Good News, Bad News

There’s a mix of good news and bad news when it comes to the uptake of biosimilars in the United States, according to the opening panel during The Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars Wednesday in Washington, DC.

“We’re not there yet,” said Murray Aitken, a senior vice president at IQVIA, in response to the panel’s title, “Are We There Yet?”

However, the good news, he said, is that there have been no “significant hiccups” in terms of adverse events or drug safety in the time that biosimilars have been on the market in the United States.

In addition, 18 biosimilars have been approved by the FDA, but that also leads into what Aitken says is the “not so great news,” because most of them have not made it to market.

For those that have, there has been varying degrees of success.

• Basaglar, a lower-cost follow-on insulin glargine referencing Lantus, has taken a 26% share of the total volume of the originator.
• Biosimilars of filgrastim have caused the market share of the reference product, Neupogen, to fall to 20%.
• However, biosimilars of infliximab have captured just 6.6% of the market, which is still dominated by reference infliximab (Remicade).

“Those are some metrics, if you like, of the limited progress that’s been made,” said Aitken.

The biosimilars are priced anywhere from 15% to 30% to 40% off the originator’s list price, which he called “not insignificant” but not the full potential of future discounts, and not as deep a price reduction that has been seen in Europe.

The moderator of the panel, Neilson Hobbs, editor of The Pink Sheet, asked Sarah Ikenberry, a health communications specialist with the FDA, how the agency is doing with the promotion of biosimilars.

The FDA is focusing on education and working to make sure everything they do is scientifically rigorous, she said, and has approved numerous biosimilars. In terms of winning over providers to biosimilars, a doctor on the panel says some patients still don’t understand the role of biologics.

“Before biologics all we had were steroids, surgery,” said Aline Charabaty, MD, representing the American Gastroenterological Association. Given the continued questions by some about biologics, biosimilars have a bigger hurdle, she said.

A physician is likely to think, “if a patient is doing well why do I want to rock the boat?” she said, when presented with the idea of a biosimilar.

“There’s lot of resistance and a lot of uncertainty,” she said, but she noted that data from Europe and Canada show similar immunogenicity, safety, and efficacy for infliximab.

Answering Hobbs’ first question, she said, “I don’t think we’re there yet, but I think we’re working hard at it.”

“I hadn’t even appreciated that we may not even be there yet when it comes to patient acceptance of biologics,” Hobbs noted.

Hobbs and Ikenberry also discussed interchangeability. Ikenberry said that in reaching out to patients and doctors, they found many of the same issues that Charabaty found. But understanding what baseline knowledge people held helped the FDA to create outreach materials.

Physicians still want more data, Ikenberry said. “The interchangeability standard is still very confusing to people,” she said.

Charabaty, however, pointed out something to consider. “In defense of physicians,” she said, “our experience comes from generic products.”

While she recognizes that biosimilars are different, physicians all have the experience of patients telling them that a generic drug worked differently than the brand.

“In people’s minds, they don’t see the difference,” she said.

Returning to the “good news, bad news” theme, Aitken said the fact that the United States is a decade behind Europe means that there is a growing stack of evidence about the use of biosimilars.

Charabaty replied, however, there is another reason for physician resistance for switching patients to a biosimilar; she called it “the feel that we could lose control, that these switches could happen without our consent?” There are also questions about whether response would be lost or if immunogenicity would start to build, she said.