FDA Streamlines Biosimilars Regulation to Cut Drug Prices
The FDA is simplifying regulations to promote the use of biosimilars, affordable alternatives to brand-name biologic drugs. The changes aim to reduce approval times and costs, potentially lowering drug prices.
Currently, biosimilars face obstacles in reaching patients due to patents and lawsuits from brand-name drugmakers. The FDA's new guidelines will no longer require expensive clinical trials to prove biosimilars' effectiveness, aiming to halve approval timelines and save manufacturers tens of millions of dollars.
Over 60 biosimilar products are already on the U.S. market, but drug spending continues to rise. The FDA's move could speed up the introduction of more biosimilars, similar to the impact of generic drugs, which represent about 90% of Americans' prescriptions but only a small fraction of drug costs. The first biosimilar, Zarxio, was introduced by Sandoz in 2015.
U.S. Health Secretary Robert F. Kennedy Jr. has criticized government bureaucracy for protecting monopolies and hindering competition. The FDA's proposed changes aim to encourage more competition, potentially driving down drug prices and increasing patient access to affordable treatments.
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