FDA announces streamlined process for biosimilar drug approvals
The US Food and Drug Administration (FDA) has announced plans to streamline the process for developing generic versions of complex biological drugs, aiming to expedite approvals for lower-cost alternatives to medications that treat various illnesses, reports BritPanorama.
These biologic drugs, derived from living organisms such as bacteria and yeast, present more manufacturing complexities than traditional chemical drugs. As a result, the alternatives known as biosimilars are subject to a unique approval pathway at the FDA.
Along with the announcement, the FDA released new draft guidance that suggests reducing the requirements for companies to conduct extensive studies to prove that a biosimilar is sufficiently similar to an existing FDA-approved product. This shift is expected to facilitate the development and availability of biosimilars.
“Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America,” said FDA Commissioner Dr. Marty Makary. He noted that streamlining the biosimilar development process could result in substantial cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans.
Although biologic medications account for just 5% of prescriptions in the US, they constitute over half of the total drug spending, according to the FDA. Currently, the agency has approved only 76 biosimilars, with a limited number of biologic drugs expected to lose patent protection in the forthcoming decade having a biosimilar in development.
Since the first biosimilar approval in the US in 2015, the FDA has stated that comparative clinical efficacy studies have minimal scientific value compared to analytical testing. The new guidance therefore aims to lessen the burden of conducting these costly and time-consuming studies for developers seeking approval.
Furthermore, the FDA intends to recommend against “switching studies” for biosimilars awaiting an “interchangeable” designation, which permits pharmacists to substitute the biosimilar without prescriber consultation. The agency emphasized that such changes align with an evolving scientific landscape while ensuring safety and effectiveness remain uncompromised in biosimilar and interchangeable biosimilar development.
Wednesday’s announcement is part of a broader initiative by the Trump administration to lower drug costs, which includes an executive order mandating drugmakers to provide medications at the lowest prices and the launch of a “TrumpRx” direct-to-consumer website for select drugs.
The FDA highlighted in a fact sheet that expensive drugs can lead to patients skipping doses and abandoning treatment, especially when insurance coverage comes with high deductibles. “With today’s action, the FDA aims to help more companies bring affordable, high-quality biosimilars to market and reduce costs for the American people,” the agency stated.
This strategy, while aimed at enhancing accessibility and affordability in the pharmaceutical market, also represents a significant shift in how the FDA approaches the regulatory landscape surrounding biologics.
