FDA looks to boost biosimilars to lower drug costs
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The Trump administration is moving to speed up approvals of copycat biologic drugs as a way to lower health costs and boost an underused market.
Why it matters: Efforts to elevate biosimilars have been thwarted by unfavorable placement on formularies and doctors' refusal to switch patients to the look-alike treatments.
- Now, the Food and Drug Administration is easing some requirements around studies that biosimilar makers conduct to compare the treatments with brand-name products.
Driving the news: The FDA on Monday changed rules to allow comparison with products approved outside the United States and to down on the need for additional studies comparing to a product licensed in the U.S.
- While some drug policy experts said the moves are a step in the right direction, they cautioned there's no guarantee they'll deliver on the administration's goals.
- "It may not lower prices, but it might, which is a good thing," said Ryan Conrad, a visiting fellow at Brookings and a former economist at the FDA.
- There are still obstacles outside of the FDA's control, including insurers and pharmacy benefit managers that may not cover certain biosimilars or may favor their own private-label products, Conrad said. And certain drugs for small patient populations can't support multiple manufacturers.
"Even if FDA makes it easier to approve biosimilars, which is something the agency has been working on for several years, then these other barriers remain," said Rachel Sachs, a law professor at Washington University in St. Louis.
- Overall, she said biosimilars got off to a "slow start" after Congress created a pathway to approval as part of the Affordable Care Act in 2010.
Yes, but: The FDA's regulatory flexibility still drew some praise on Monday.
- Former FDA Commissioner Scott Gottlieb called it "important streamlining of [the] path to getting low-cost biosimilars to the market."
- Juliana Reed, executive director of the Biosimilars Forum, a trade group for the industry, said the FDA's move was "incredible."
- "Nobody knew what a biosimilar was 10 years ago," she said, noting that it takes time for the industry to grow and succeed. "With anything new, we find what works and what does not work."
Between the lines: One of the highest-profile use cases for biosimilars has been AbbVie's blockbuster anti-inflammatory drug Humira.
- Biosimilar versions struggled even after the brand-name version lost market exclusivity in 2023, though business has started to pick up.
- Biosimilars backers said another obstacle was the way AbbVie used "patent thickets" to file overlapping intellectual property claims on the product and delay competitors from getting on the market.
- Bipartisan legislation targeting the practice has been stalled in Congress for years.
The intrigue: There are also congressional efforts to go further on the type of approval streamlining that the FDA announced on Monday.
- Bipartisan legislation would cut the need for additional switching studies with the brand-name product. Critics say those requirements are duplicative and simply add time and expense.
What we're watching: Whether the FDA's focus on biosimilars can meaningfully boost prospects for big players like Sandoz, Pfizer and Amgen.
- Reed said the Medicare drug price negotiation program could serve as an incentive for brand-name drug companies to break down barriers to biosimilar competition, since drugs with competitors on the market are exempted.
- "If you don't want to be negotiated, you sure want that biosimilar to get on the market," she said.
