Biosimilars are a type of biological product, derived from living organisms, offering new avenues for treating various complex diseases. They aim to provide patients with additional treatment options for conditions that traditionally rely on often costly reference biological products. This article will clarify the nature of biosimilars, detail their U.S. regulatory pathway, present the current number of those approved, and discuss their broader implications for the healthcare system.
What Are Biosimilars?
Biosimilars are biological products highly similar to, and with no clinically meaningful differences from, an existing U.S. Food and Drug Administration (FDA)-approved reference biological product. Unlike generic drugs, which are exact copies, biologics are large, complex molecules with inherent variability due to their production in living systems. A biosimilar is not an identical copy but demonstrates analytical and clinical similarity to its reference product in terms of safety, purity, and potency. The manufacturing process involves living cells and advanced biotechnological methods to ensure the final product closely mimics the original biologic.
This careful development ensures patients can expect the same clinical outcomes from a biosimilar as from the reference product. Biosimilars expand treatment choices for patients and healthcare providers. Their introduction fosters competition, which can lead to reduced costs for these often expensive medications. Biosimilars improve patient access to necessary biological therapies for various serious conditions.
How Biosimilars Are Approved
The U.S. Food and Drug Administration (FDA) oversees the rigorous approval process for biosimilars in the United States. This regulatory pathway was established under the Biologics Price Competition and Innovation Act (BPCIA) of 2009, creating an abbreviated licensure pathway for biological products. The approval process requires extensive data to show the biosimilar is highly similar to the reference product. This involves comprehensive analytical studies comparing structural and functional characteristics.
Preclinical and clinical studies, such as pharmacokinetic and pharmacodynamic comparisons, confirm no clinically meaningful differences. A higher standard of approval exists for “interchangeable” biosimilars. To meet this, a manufacturer must provide data demonstrating the biosimilar can be substituted for the reference product without healthcare provider intervention, and that it is expected to produce the same clinical result in any given patient. This includes showing that the risks of alternating or switching between the interchangeable product and the reference product are no greater than using the reference product alone.
Current Approvals in the US
As of July 16, 2025, the U.S. Food and Drug Administration (FDA) has approved 72 biosimilars in the United States. These important approvals span various therapeutic areas, including medications for cancers, autoimmune diseases, and diabetes. The most recent approval was Kirsty (insulin aspart-xjhz) on July 15, 2025.
Among the approved biosimilars, 21 have achieved the higher designation of interchangeability. This means these specific biosimilars can be substituted for their reference product at the pharmacy level, similar to how generic drugs are interchanged. The FDA’s official resource for tracking all licensed biological products, including biosimilars and interchangeable biosimilars, is the “Purple Book.” This searchable online database provides the most current and comprehensive information on approved biological products and their status.
Broader Impact on Healthcare
The increasing number of biosimilar approvals has a substantial impact on the U.S. healthcare landscape. A primary benefit is the potential for significant cost savings for patients, healthcare systems, and payers. As more biosimilars enter the market, they introduce competition to original biological products. This competition can drive down prices, making advanced therapies more affordable and accessible.
Biosimilars expand treatment options for patients. This expanded access is important for individuals requiring long-term biological therapies for chronic conditions. The presence of biosimilars helps alleviate financial burdens, allowing more patients to initiate or continue necessary treatments. Biosimilars contribute to a more competitive and patient-centered biologics market, fostering innovation and improving the sustainability of healthcare expenditures.