The U.S. Food and Drug Administration (FDA) has developed a new policy aimed at simplifying the regulatory pathway for biosimilars to accelerate their market entry and reduce costs.
A biosimilar medicine is an analog of complex biological products, created using living cells or organisms. Unlike generics, it is not an identical chemical copy but has similar efficacy and safety to the “original medicine.” Biosimilars allow us to reduce the financial burden of treatment for patients with cancer, autoimmune, and other severe chronic diseases.
What Is Behind the FDA’s New Regulations?
The main priority of the FDA’s plan is the removal of duplicated clinical efficacy studies from the biosimilar approval process. The project, published in October 2025, notes that if a Comparative Analytical Assessment confirms a High Similarity of the biosimilar to the original product, it will be sufficient to study only pharmacokinetics and assess immunogenicity. As a result, companies will save resources and time, which will sharply accelerate the licensing of biosimilars.
Another element of the FDA’s new approach is granting biosimilars Interchangeable Status. This means that pharmacies can automatically substitute the reference biological medicine with the biosimilar without changing the prescription, just as happens with standard “generic” medications. This step can sharply increase the uptake of biosimilars and strengthen market competition to reduce prices.
As FDA Commissioner, Dr. Marty Makary, noted, biosimilars will bring significant financial benefits to healthcare. Despite 76 biosimilars being approved in the U.S. since 2010 (including treatments for oncological, autoimmune, and diabetes diseases), their market share is still low—only 5% of prescriptions and up to 20% of the biological market. Accelerating the regulatory process can change this dynamic.
Biosimilars represent a low-cost alternative to expensive biological medications, ensuring broad accessibility to critically important therapies. According to recent studies, the entry of biosimilars into the market caused a moderate reduction in the price of branded biological drugs in the Medicare Part B system: 7.4% after 1 year, 31.7% after 3 years, and 43.1% after 5 years. However, this reduction falls short of the rates recorded for small-molecule generic medications, which indicates the need to change regulatory policy.
Controversial Aspects in the Pharmaceutical Sector
Although the FDA is trying to accelerate the market entry of biosimilars, some organizations, such as the Alliance for Safe Biologic Medicines (ASBM), do not favor simplifying this process. They believe that the biosimilar approval process should not be equated with the less stringent requirements for generic medications. Unlike generics, biosimilars are complex molecules of biological origin, and fully guaranteeing the identity of their structure is almost impossible.
It is precisely because of this structural complexity that critics argue that mandatory clinical efficacy studies should be maintained, as only they confirm that the biosimilar is as clinically safe and effective as the original. Their primary concern is that removing these studies may undermine the trust of doctors and patients in these products.
Both American (FDA) and European regulatory bodies fully recognize the complex nature of the biosimilar approval process and have developed regulatory frameworks that maintain a balance between rigor (ensuring patient safety) and efficiency. This balance is expressed in the fact that the volume of clinical trials and the evidence for interchangeable status are assessed individually. That is, clinical data are only requested “as needed.”
Public hearings and workshops, which concluded in October 2025, were held to refine this regulatory model. Comments received from the public and the industry will be crucial for developing the final guidelines that will determine the marketing pathway for biosimilars.
What Is the Next Step in Biosimilar Development?
The FDA plans to publish a draft of its strategic plan within the next 12 months, which will detail specific mechanisms for promoting interchangeable biosimilar products. The updated project related to the reduction of clinical testing was officially published in November 2025, and the deadline for public comment expires in January 2026.
This regulatory transformation aims to establish a dominant place for biosimilars on the market and turn them into accessible options, thereby increasing the financial accessibility of healthcare across the country.
Source: FDA; Federal Register
