The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving lower-cost versions of some expensive drugs to speed access to cheaper alternatives.
The decision affects biosimilars, or medicines that are nearly identical copies of biological drugs made from living cells.
These drugs are similar to generics, but their production is more complicated. It is often used to treat serious illnesses such as cancer. diabetes And autoimmune diseases.
Several top-selling brand-name drugs already have biosimilar versions, including: Herceptin for breast cancer, Lantus for insulin and Humira for arthritis and other autoimmune diseases.
Under the new guidelines, biosimilar developers will no longer have to conduct costly and lengthy clinical trials to prove that their version is as effective as the original, the New York Times reported.
Instead, you only need to show that the drug’s structure and manufacturing process are similar to the branded version.
The FDA also plans to make it easier for pharmacists to replace brand-name drugs with biosimilars, similar to generic drugs.
“For too long, government bureaucracy and regulatory barriers have protected monopolies and stifled competition,” the U.S. Surgeon General said. Robert F. Kennedy Jr. said at a press conference announcing the changes:
FDA Commissioner Dr. Marty McCurry It said the change would cut the approval period in half, from the current five years to eight years, and save companies tens of millions of dollars in research costs. He said these savings could ultimately lower prices for patients.
Industry experts said the move could help but may not address the biggest obstacle preventing biosimilars from reaching customers.
Branded pharmaceutical companies have long used patent protection and litigation to delay the launch of biosimilars even after FDA approval.
“I don’t think these regulatory changes are actually relieving bottlenecks,” said Brian Skorney, a pharmaceutical industry analyst at investment bank Baird. said.
Generic and biosimilar drugs currently account for about 90% of prescription drugs in the U.S., but they only account for a very small portion of overall drug costs, The Times reported.
The biological drugs that biosimilars are designed to replace remain a major driver of growth in pharmaceutical spending.
PHRMAa lobbying group for big-name drugmakers, said Wednesday that pharmacy benefit managers, the middlemen who negotiate drug prices, also have a responsibility to limit access to biosimilars.
Kennedy also accused major pharmaceutical companies of manipulating the rules and lobbying to protect their profits.
“The pharmaceutical industry manipulated the regulations,” he said.
Since the first biosimilar was approved in 2015, more than 60 biosimilars have entered the U.S. market, but the process has been slow. FDA officials said this new initiative aims to change that by making the process faster and cheaper for both patients and drug companies.
Additional information
The American Cancer Society explains more about: Biological equivalent drug.
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