FDA Should Forge Ahead on Biosimilar Drug Reviews: A Rheumatologist's Opinion

In an opinion piece for Morning Consult, practicing rheumatologist Angus B. Worthing, MD, advises that it’s more important than ever that the FDA forge ahead with biosimilar drug review, where the safety stakes are high but additional FDA-approved therapies can have real value and impact for American patients. Physicians prescribing biosimilars need to know the new biosimilars are not only affordable, but also entirely safe for our patients, and this is possible only if there is a sufficiently large workforce at the FDA, he concludes.

Biologics are powerful but complex therapies, life-changing treatments for diseases such as rheumatoid arthritis (RA), ulcerative colitis, psoriasis, and several forms of cancer. The problem is, they are also prohibitively expensive, and even patients with health insurance coverage struggle to afford them. That is why it is more important than ever that the FDA adhere to its dual mandate—to promote patient access while ensuring consumer safety, Dr Worthing states. It’s a delicate balance to strike, especially in biosimilar drug review, an area of potentially high safety stakes and high value and patient impact.

More than 52 million Americans have rheumatic diseases, and having access to approved biologic therapies is critically important because these treatments can dramatically improve long-term patient outcomes, says Dr Worthing. “These drugs are highly effective, helping my patients to manage pain, avoid long-term disability, and lead healthy, full lives.” He adds that patients and clinicians welcome the introduction of biosimilars because they have the power to increase competition and eventually lower the cost of biologics. The first FDA-approved biosimilar treatment of rheumatic diseases went on the market in 2016 (Inflectra, a biosimilar to the reference infliximab drug, Remicade), and other biosimilars for treatment of rheumatic diseases are currently undergoing FDA review—good news for patients who struggle to access and afford the biologic therapies they need to manage their conditions, Dr Worthing writes.

Biosimilars hold great promise but they come with high stakes because of their complexity. Even small changes in the manufacturing process can lead to ineffectiveness or dangerous interactions with the patient’s immune system, Dr Worthing explains. “It is imperative that there be full transparency in biosimilar naming, labeling, and post-market surveillance practices, as well as a robust FDA workforce to support the biosimilars review and regulatory process,” he concludes. Physicians must know precisely what they are prescribing and patients must know what they are taking. Distinct names, clear labeling, and consumer-friendly dispensing practices must be priorities. While the FDA has made some good progress on this front, Dr Worthing writes, it must now issue and implement final industry guidances.

Congress can support these efforts, he notes, by ensuring adequate funding to enhance and expedite the FDA’s review of biosimilar therapies and to issue industry guidance. This is a goal that can be achieved if Congress creates a dedicated program for biosimilar review with its own source of funding, similar to what exists for prescription drugs, generics, and medical devices. In addition, Congress should also quickly reauthorize the Biosimilar User Fee Act, under which the FDA is allowed to collect user fees on biosimilar products in order to fund the review process. The law will expire in September 2017.

Finally, the incoming administration must enact hiring reforms to help the FDA hire qualified reviewers, Dr Worthing recommends, because right now it is too difficult to find highly qualified employees. The 21st Century Cure Act authorized decision makers to make a change in this process, he says, and there are many ways the new administration could tackle this issue. For example, federal agencies can use market surveys of salaries in related competing industries where FDA candidates might currently work in order to better align pay rates that will attract the best talent with expertise to study biologics.

Innovative and efficient onboarding of experts in the complex field of biologic therapies must be a top priority in the years ahead if biosimilars are to reach the many patients who would benefit from these therapies, Dr Worthing concludes. “We can have the best of both worlds, providing patients with state-of-the-art treatments and manageable prices. It is imperative that our policymakers dedicate more time and resources towards biosimilar policy at the FDA to realize that goal.”