What are biosimilars? Biosimilars are lower-cost alternatives to existing medicines that treat some of life’s most serious diseases. These complex therapies are made by living cells and have no clinically meaningful differences in the safety profile, potency, and purity as compared to the reference biologics. Because biosimilars create new choices and competition in the biologics marketplace, they have the potential to lower costs for patients and the healthcare system, meaning patients may have more options when battling challenging diseases like cancer, rheumatoid arthritis, psoriasis and inflammatory bowel disease.

Biosimilars work the same way, but cost less. Because biologics are complex therapies that are more difficult to manufacture than traditional medicines, while they account for less than one percent of prescriptions filled, biologic products equal close to one-third of all drug spending, according to a New England Journal of Medicine study. And given that biosimilars cost less than reference biologics, they have the potential to dramatically lower costs in the U.S. health care system. One study found that increased access to biosimilars could cut U.S. health care spending by as much as $54 billion over the next decade. And according to the FDA, if Americans had the opportunity to purchase FDA-approved biosimilars, they could have saved more than $4.5 billion in 2017.

Biosimilars are proven to be safe alternatives. Key to the biosimilars experience is that they don’t have any meaningful difference in safety or efficacy from the reference biologic, and accordingly that they perform the same in clinical practice. The FDA approves biosimilars only after they meet the agency’s rigorous standards for approval. The manufacture of biosimilars is complex and must be precisely controlled to obtain consistent results, ensuring that patient safety above all else is maintained.