Biosimilar medicines are the key to success

The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, ulcerative colitis and Crohn’s disease — depend on safe and effective biological medicines called tumor necrosis factor (TNF) inhibitors. These are highly effective but can cost as much $48,000 annually for a single patient.

Historically, biologics have enjoyed long market life because there was no approval pathway for biosimilars or follow-on biologics, that are copies of an originator biologic medicine. While not exactly generic copies, biosimilars have the potential to affect the market the same way: by introducing competition and driving down costs, while maintaining safety and efficacy. Congress created such a path in 2010, through the Biologics Price Competition and Innovation Act (BPCIA).

{mosads}Results to date are mixed. The U.S. Food and Drug Administration (FDA) has approved six TNF inhibitor biosimilars, however, only two TNF inhibitor biosimilars are on the market, and the FDA approval pathway for approving biosimilars as “interchangeable” has not been finalized. Biosimilars are lowering the price of biologics in the US, being priced 35 percent lower than the originator biologic. Yet, well after FDA approval, they only represent six percent of the market. If instead they had a 50 percent share, savings from just these two biosimilars would top half a billion dollars, reports the Pacific Research Institute.

A promising development is the FDA’s recently released Biosimilars Action Plan aimed at spurring competition in the market. Key areas of focus include improving the efficiency of the product development and approval process.

However, as a physician who prescribes biologics and supports growth of the biosimilars market, prescriber confidence in the safety and effectiveness of biosimilars plays at least as important a role in whether biosimilars meet their intended purpose of reducing the costs of biological medicines. How the approval process is altered by the Action Plan must not have the unwanted effect of jeopardizing our confidence in biosimilars.

As an important example, the FDA has already issued carefully crafted draft guidance on approving interchangeable biosimilars, including appropriate standards to ensure patient protection. Interchangeability ultimately could set the terms for when pharmacists and drug plans can substitute a biosimilar for an original biologic without the involvement of physicians and patients.

A critical patient protection in the draft interchangeability guidance involves switching studies to confirm the safety and efficacy of alternating between a biosimilar and its originator biologic. Reflecting likely patient experience with changing formularies, the guidance recommends at least three switches between the products, so that clinical trial subjects are exposed to each drug twice (ie, A to B to A to B).

Citing the need for studies with multiple switches, the American Medical Association (AMA) in June called on the FDA to finalize the interchangeability guidance “with haste.” This, said the AMA, would allow transition to an era of less expensive biologics that provide safe, effective patient treatment options.

Should the FDA amend its guidance to require fewer than three switches, in an effort to improve the efficiency of the approval process, patients would be exposed to uncertain risks, and prescriber confidence would be undermined. Released in January of last year, I urge the FDA to finally publish this guidance — without delay.    

On Sept. 4, the FDA will convene a public hearing on its Biosimilars Action Plan to gain stakeholder insights on how to facilitate greater availability of biosimilar and interchangeable products. Let this hearing provide the much-needed impetus to finalize the interchangeability guidance and strengthen prescriber and patient confidence: the key to developing a successful biosimilar market where products are not just approved, but used.  

Angus B. Worthing, MD, serves as chairman of the American College of Rheumatology (ACR) Government Affairs Committee, is a rheumatologist for Arthritis and Rheumatism Associates, P.C. and is a member of the Biologics Prescribers Collaborative (BPC).