The Food and Drug Administration announced on Wednesday that it would ease regulatory roadblocks for low-cost copycat versions of certain medicines.
Biosimilars, as the copycats are called, are seen as a crucial way to drive down drug prices. They are akin to generics of biologic drugs that are made through complex biological processes. Some well-known blockbuster drugs are now available as biosimilar competitors, including Herceptin, for breast cancer; Lantus, a widely used insulin; and Humira, for autoimmune conditions like arthritis.
The F.D.A. said it would advise drug developers that they generally no longer need to conduct expensive and time-consuming clinical trials aimed at showing that the copycat is just as effective as the original brand-name product. The agency also said it would push to make it easier for pharmacists to swap in biosimilars when dispensing a prescription, as is standard with generics.
“For too long, government bureaucracy and regulatory barriers have protected monopolies and stifled competition,” Robert F. Kennedy Jr., the health secretary, said at a news conference Wednesday announcing the changes.
The Trump administration’s moves could help accelerate some biosimilars, but they stop short of addressing the most stubborn obstacles that have suppressed the copycats in the United States. The makers of brand-name drugs have used patents and lawsuits to block biosimilars from reaching the market, in some cases for years after the copycat wins F.D.A. approval. And when the copycats are introduced, they have been slow to gain market share.
“I don’t really see this regulatory change as an alleviation of the real bottleneck,” Brian Skorney, a drug industry analyst at the investment bank Baird, said on social media.
Generic and biosimilar drugs represent about 90 percent of Americans’ prescriptions, but only a tiny fraction of drug costs. The brand-name biologics that biosimilars compete with have emerged in recent years as a huge driver of drug spending.
The makers of biosimilars often spend several years and tens of millions of dollars conducting a clinical trial to show that its version as is effective as the original brand-name version. Under the F.D.A.’s proposed changes, developers would still have to show that their molecule and manufacturing process are similar.
Dr. Marty Makary, the F.D.A. commissioner, said at the news conference that the move would halve the current five- to eight-year timeline to win approval for a biosimilar. He said the changes would save biosimilar manufacturers tens of millions of dollars in development costs, saying that could be passed down in the form of lower costs for payers and patients.
Unlike traditional pills synthesized through chemistry, biosimilars are made inside living cells and typically given as infusions or injections.
When the first biosimilar was approved in 2015, there was widespread hope that the class would drastically drive down drug costs. More than 60 biosimilar products are now on the market in the United States. But biosimilars have been slow to gain traction, and drug spending has continued to increase.
In his remarks on Wednesday, Mr. Kennedy accused brand-name drugmakers of lobbying to stymie biosimilars to protect their profits. “The pharmaceutical industry rigged the rules,” he said.
PhRMA, the lobbying group that represents brand-name drugmakers, said in a statement on Wednesday that the real problem in the biosimilar market was different. The group blamed industry middlemen — giant companies known as pharmacy benefit managers — for often excluding biosimilars from their lists of covered medicines.
Christina Jewett contributed reporting.
Rebecca Robbins is a Times reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.
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