Biosimilar drugs offer promise for US health care system

The Food and Drug Administration’s recent approval of new treatment options for patients suffering from conditions such as cancer, rheumatoid arthritis and ulcerative colitis is the latest recognition of a nascent prescription drug sector known as biosimilars. The FDA’s actions are critical for promoting a vibrant U.S. marketplace for biosimilars, which have the potential to reduce costs in our health care system and increase access to care for millions of patients.

While most Americans may be unfamiliar with the term “biosimilars,” they are commonly being used throughout Europe, Australia, South Korea and elsewhere to treat a range of conditions including cancer, anemia, inflammatory bowel disease and autoimmune disorders such as psoriasis and rheumatoid arthritis. At the same time, they are reducing costs and increasing access to care in those countries.

{mosads}Instead, more Americans are likely familiar with drugs such as Humira, or Enbrel which are commonly used to treat rheumatoid arthritis. These are examples of originator “biologics” — branded, highly specialized drugs that are made in living cells rather than via chemical synthesis like most drugs.

While biologics were a revolutionary medical breakthrough and are enormously valuable, the time and investment associated with developing biologics — up to 15 years and more than $1.2 billion in some cases — and the lack of competition in the marketplace has led to high prices for patients who use them. This can create a barrier to care while driving up costs throughout the nation’s entire health care system. In fact, while only 2 percent of the population uses biologic drugs, they account for 40 percent of prescription drug spending in the U.S.

A biosimilar, on the other hand, is essentially what its name implies — a highly similar version of a biologic drug that is designed to match the branded originator biologic. Because they are made in living cells, biosimilars cannot be a perfect copy of their biologic “reference drug,” they do provide the same medical benefits to patients with no differences in safety or effectiveness. The FDA can only approve a biosimilar for patient use if there are no meaningful clinical differences from its reference drug. As a result, patients and physicians can expect the same clinical results when using a biosimilar or the biologic reference drug.

Biosimilars can also be far less expensive, because biosimilar producers can rely on safety and efficacy information from the reference product instead of repeating large-scale clinical trials. In fact, biosimilars are expected to cost up to 35 percent less than their reference drugs — which has the potential to offer major savings for patients and increase access to care. The Rand Corp., for instance, has predicted that by 2024 biosimilars will reduce direct spending on biologics in the U.S. by more than $44 billion.

However, the U.S. has yet to realize the growth in the biosimilars market already seen overseas. In Europe, for example, biosimilars have been available to patients for more than a decade, with more than 20 biosimilar products now on the market. There has been more than 700 million patient days of treatment with biosimilars in Europe, and there are no new safety or efficacy concerns that are not already been known from the biologic reference drug. By contrast, the FDA has approved seven biosimilars, with only three of those currently available to patients.

As more biosimilars are approved by the FDA, patients and doctors need to be better informed about the safety and efficacy of biosimilars. Countries such as Australia and Germany are accomplishing this through national education campaigns that raise awareness about the benefits of biosimilars and offer incentives leading to further adoption of their use.

Regulators continue to take important steps in boosting biosimilars in the U.S. with providing guidance to manufacturers and approving biosimilars.  But there is more work to be done, and it is critical that education and policies are advanced to support the biosimilars reaching the marketplace so that patients can access these safe, effective and more cost-efficient medicines.

Stacie Phan is President of the Biosimilars Forum.