(StatePoint) Biological drug products (biologics) — which can be made of sugars, proteins, living cells, tissues, or a combination of these — are providing new options for patients with conditions such as diabetes, arthritis, chronic bowel diseases, macular degeneration, and multiple sclerosis, among others. In many cases, these therapies are helping shift treatment from acute care to long-term disease management. Doctors and evidence suggest that certain cancers are increasingly being managed as chronic conditions thanks to innovative biologics. But there is a catch: These drugs can be notoriously expensive, with or without insurance.
That is where biosimilars step in. Biosimilars are highly similar versions of complex biologics that deliver the same clinical benefits, expanding access to advanced therapies that might otherwise be out of reach. Biosimilars are designed to provide the same clinical benefits as their reference biologics, often at lower cost. Biosimilars delivered nearly $20 billion in savings in 2024 alone, according to a recent analysis published in JAMA.
“Access isn’t just about price, it’s about supply, competition, and whether medicines actually reach patients. Biosimilars are the next wave of access and affordability, helping more patients access high-quality biologic treatments reliably and at lower cost,” says Chintu Patel, co-founder and co-chief executive officer of Amneal.
Amneal, a U.S.-based biopharmaceutical company focused on complex medicines, is working to expand access to high-quality biosimilars. This comes at a time when more biologic medicines are losing exclusivity, creating a significant opportunity to offer patients more affordable options. With additional biosimilar launches expected over the next several years, Amneal is continuing to build momentum in this area. Amneal’s biosimilar portfolio reflects a focus on high-quality standards, reliable supply and broad patient access. For more information, visit Amneal.com.
As biosimilars become more widely available, patients may still have questions about how these medicines work. Here are some common questions about biosimilars and what patients should know:
How does the FDA determine whether a biosimilar can be approved?
Before approving a biosimilar, the U.S. FDA requires evidence that there are no clinically meaningful differences from the reference biologic medicine in terms of safety, purity and effectiveness.
What does it mean if a biosimilar is not designated as “interchangeable”?
An “interchangeable” designation relates to how a biosimilar may be substituted at the pharmacy, subject to state laws. It does not mean the biosimilar is safer or more effective than another FDA-approved biosimilar.
Can patients safely switch from a reference biologic to a biosimilar?
Research has shown that changing from a reference biologic medicine to a biosimilar does not reduce safety or effectiveness. A comprehensive review of studies from the U.S. FDA involving more than 5,000 patients found no difference with safety issues or immunogenicity in patients who were switched and those who remained on their reference biologic or biosimilar.
Do biosimilars have to meet the same quality standards as other biologic medicines?
Yes. Biosimilars must meet the U.S. FDA’s rigorous standards for quality, safety and effectiveness before they can be approved. Patients can typically find manufacturing information on a product website, product packaging or approved labeling. As more biosimilar products become available, patients can anticipate more options and reduced drug prices.
