Biosimilars: A Safe and Effective Option for Patients

It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients. But FDA-approved biosimilar versions of these brand-name biologics can provide competition in the market and help drive down costs, ensuring that all patients benefit from advances in biopharmaceutical research. Current estimates suggest that consumers could save as much as $250 billion during the first 10 years of biosimilar availability.

The Biosimilars Council and our members are working to increase awareness of biosimilar medicines among all stakeholders and to educate patients and healthcare professionals that these medicines have the same safety and efficacy profiles of biologic medicines (reference products). Similar to the advent of generics more than 35 years ago, biosimilars have the potential to increase patient access to innovative biopharmaceutical treatments.

Biosimilar Safety and Efficacy

The process for developing biosimilars is complex; and companies that manufacture biosimilars are committed to providing safe, effective products to patients. The FDA requires biosimilar manufacturers to adhere to the same safety monitoring requirements of brand biologic manufacturers. There has been more than 10 years of biosimilars patient-use in the EU, no difference in health outcomes between patients who use a biosimilar and those who take the original branded biologic medicine has been documented.

FDA-approved biosimilars have the same mechanism of action as the approved brand biologic counterpart—meaning the biosimilar works the same way as the reference product. In Europe, nearly 35 biosimilars are available in at least eight therapeutic areas. But the United States has a lot of catching up to do—to date, the FDA has approved nine biosimilars and only three are available to patients due to ongoing litigation.

Biosimilar Access and Savings

Most biologic medicines entering the market are expensive and highly specialized. Prices continue to climb, with some treatments costing tens of thousands of dollars per year. While only 2 percent of the U.S. population uses them, biologics account for 40 percent of prescription drug spending in the United States, which reached a record $425 billion in 2015. Like generic drugs, which saved the U.S. healthcare system $253 billion dollars in 2016, biosimilars have the potential to increase competition in the market, which will help lower the cost of biologic medicines and increase patient access to biopharmaceutical advances that increase the quality and length of their lives

Coinciding with our annual conference this past fall: Leading on Biosimilars, we partnered with Avalere Health to release results of a new patient access study, “Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medicines.” 1.2 million U.S. patients could gain access to biologics by 2025 as the result of biosimilar availability. Data also suggest that women, lower income, and elderly patients benefit most from access to biosimilar medicines. But first, they have to get to the market.

Unfortunately, Risk Evaluation and Mitigation Strategies (REMS), the safety strategy that the FDA requires for up to 40 percent of new drug approvals, is not always being used as intended. Instead, some brand drug companies capitalize on loopholes in REMS to delay market entry of biosimilars. They do this by denying biosimilar makers access to samples of their product. Without access to samples, pharmaceutical scientists are missing the building blocks they need to conduct the research required before biosimilars can enter the market. 

The potential lost savings because of these delay tactics are staggering. It’s estimated that restricting access to samples and delaying biosimilars results in $140 million in lost savings for every $1 billion in biologics sales.

FDA-approved biosimilars can lower the cost of expensive brand-name biologic drugs and increase patient access to life-saving medicines. They offer the potential for tens of billions of dollars in patient, insurer and health system savings—but only if patients can access them in a timely manner.

Educating Physicians, Patients and Providers

Because biosimilars are new to the U.S. healthcare system, is important that all stakeholders learn more about their safety, efficacy and value. To help address this, our updated handbook is designed to be a reference tool for all stakeholders, and in particular patients and healthcare professionals, interested in learning more about biosimilars and interchangeable biologics.

This and other biosimilar resources are available for physicians, patients and providers on the Biosimilars Council website.