Fact: Too Many Myths About Biosimilars Persist

While many Americans are unaware of biosimilar drugs, they may hold the key to increasing access to care for patients while reducing the nation’s health care spending rate. But the United States will only be able to develop a robust biosimilars marketplace if physicians and patients have all the facts about this emerging health care sector.

Biosimilars are versions of biologic drugs, which, unlike synthetic drugs, are complex compounds made from living organisms. Because biologics are costly to produce, patients end up paying a high price for treatment. But when a biologic’s patent expires, its formula can be used as a blueprint to develop new, highly similar drugs known as biosimilars.

The developing biosimilars drug sector offers great promise to those suffering from debilitating and chronic conditions, but it has been met with skepticism by critics who say that regulators need to issue more stringent guidelines to assess the safety and efficacy of these treatments.

But claims like this are indicative of the many misconceptions about biosimilars that persist among physicians, patients, and others in the health care sector. To ensure the development of a robust biosimilars marketplace, which has potential to bring down costs throughout our health care system, we need a public dialogue informed by the facts.

Biosimilars undergo a rigorous approval process by the Food and Drug Administration before being approved as a treatment option for patients. Only if studies demonstrate there are no clinically meaningful differences between the biosimilar drug and its reference biologic in terms of safety, purity and potency is a biosimilar approved.

After they have met the FDA’s standards, biosimilars can be prescribed as a more affordable alternative to biologics. This leads many to believe that if biosimilars cost less, than they must be less effective and not work as well. But biosimilars cost less than biologics because biosimilar manufacturers can rely on safety and efficacy data from the reference product to support product development rather than conduct new independent clinical trials. This brings down development costs, and allows those savings to be passed on to the healthcare system.

In fact, The RAND Corporation has predicted that biosimilars could reduce direct spending on biologics by $54 billion from 2017 to 2026, increasing access to millions of patients suffering from chronic conditions such as cancer, anemia, and autoimmune disorders.

Despite this enormous potential for patients in the United States, some say that there is insufficient real-world evidence for physicians to truly know whether biosimilars can live up to their promise. But these critics need only look to Europe, Australia and South Korea, where biosimilars have long been in use, and independent patient studies have repeatedly confirmed the safety and effectiveness of biosimilar drugs.

A similarly robust biosimilars marketplace could be on the horizon in the U.S. The FDA’s recently launched education campaign can help better educate physicians, patients and others in the health care sector about biosimilars. But it is incumbent upon all of us to get informed about these treatments. To do so, we need to jettison the myths, move forward with the facts, and help these safe and effective treatments become more widely accepted.


Stacie Phan is president of the Biosimilars Forum.

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