The Context for Biosimilars

Health care is among the most important parts of our lives. Whether it’s a routine check-up, cancer treatment, or something in between, everyone deserves to feel confident that they are receiving the best care possible. Having access to affordable treatment options is integral to that experience -- especially at a time when American families face rising health care costs.

The good news is that we have the potential to save billions in U.S. healthcare systems spend by increasing patient access to biosimilars. The difficult part is that many patients are blocked from accessing biosimilars because of industry competition or complicated insurance policies.

What are Biologics and Biosimilars?

Biologics are medicines created by living cells, which treat a range of serious illnesses from cancer to Crohn’s disease, rheumatoid arthritis, and irritable bowel syndrome. They are both typically delivered through injection or infusion.

For each biosimilar medicine, there is a reference biologic, meaning that a patient can use either medicine to treat the same disease or condition. In fact, there are no clinically meaningful differences between the safety, purity, and potency of a biosimilar and its reference biologic. That’s why they are called “similars.” And as with all prescription medicines, biosimilars have to go through the FDA approvals process before doctors can start prescribing them to patients.

Why Does Broader Access to Biosimilars Matter?

At a time when healthcare spend is on the rise, many American patients are still unable to access biosimilars. The reason this matters is that broader access to biosimilars has the potential to cut U.S. healthcare spending by $54 billion over the next decade, according to a study from the RAND Corporation.¹ This could be a big missed opportunity.

In fact, although the U.S. biosimilars market is still quite new, Europeans have had widespread access to biosimilars since 2004. The reason is that some drug manufacturers discourage U.S. insurance companies from bringing biosimilars into the market because they don’t want new biosimilars to compete with their existing biologics. As a result, many private U.S. insurance companies refuse to cover biosimilars, preventing millions of Americans from accessing treatments that could save billions in U.S. healthcare systems spend.

Even if an insurer does cover a biosimilar, 1 out of every 2 insured Americans still have to face what’s called a “fail first” policy. This means that even if a patient is prescribed a specific biosimilar by their doctor, their insurance requires them to try the brand biologic first. Only if they don’t get better will they get access to the biosimilar. This makes it much harder for both patients and doctors to use biosimilar medicines that could create savings in the healthcare system.

What Can We Do to Improve Access to Biosimilars?

Given their potential cost savings, creating broader access to biosimilars is not only the right thing to do for patients and doctors, but can also help save money throughout the healthcare system. However, we can’t effect this change alone. We urgently need Congress to create new legislation that makes it easier for American patients to get greater access to biosimilars.

This is your opportunity to share your voice as a concerned citizen or patient. Let’s encourage our Senators and Representatives to take broad action to increase patient access to biosimilars, and to ensure that we are working toward a healthier America. Sign up and contact Congress today!

¹https://www.rand.org/pubs/perspectives/PE264.html