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Biosimilar Interchangeability Draft Guidance Strikes the Right Balance Between Speed and Safety


As US lawmakers and regulators focus increasing attention on the problem of high drug prices, the rollout of biosimilars—and specifically interchangeable biosimilars—represents a key aspect of reducing nearly a quarter of the country’s pharmaceutical spend. The FDA’s recent draft guidance on biosimilar interchangeability received considerable attention from industry stakeholders, with more than 50 comments submitted by the close of the FDA comment period.

As one of the few specialties to prescribe and administer biologic therapies, the American College of Rheumatology (ACR)—a professional association that represents the nation’s rheumatologists, rheumatic disease researchers, and other rheumatology health leaders—believes the draft guidance strikes the appropriate balance of ensuring safety and transparency while also bringing new therapies to the market as efficiently as possible. From the ACR’s perspective, this balance will be key to increasing biosimilar utilization and competition in the marketplace while simultaneously driving down the cost of these therapies for patients.

Biologics are a life-changing treatment option for millions of Americans who live with debilitating rheumatic diseases such as rheumatoid arthritis and psoriatic arthritis, helping patients manage pain while also slowing disease progression and preventing disability. Although highly effective, biologics are also extremely expensive, causing frustration for both patients and rheumatologists alike. After all, what use is a life-changing drug if a patient cannot afford it?

The cost challenges associated with access and adherence to biologic therapies is the primary reason the rheumatology community has welcomed the advent of biosimilars. The ACR believes the introduction of safe and effective biosimilars will be critical to increase competition and drive down costs in the biologics marketplace.

However, the clear need to bring new therapies to market must not supersede safety and efficacy. Prescribing doctors need to be assured of the scientific validity of the criteria being used to label a biosimilar as “interchangeable” with a biologic. We also need to have confidence that it is safe to prescribe the lower-cost alternative in place of the reference product and that switching back and forth between the 2 will not produce dangerous side effects or cause the drug not to work.

The safety stakes are high and the ACR commends the FDA’s leadership in developing appropriate draft guidance that addresses 2 important issues:

  • The draft guidance would require manufacturers to use robust switching studies to determine whether alternating between a biosimilar and its reference product impacts drug safety or efficacy. Such studies are vital—they help deliver a clear understanding of what patients are likely to experience with changing formularies in a multi-payer, multi-state, and ever-changing market.

Access to, and trust in, the data from such studies will undoubtedly inform prescribing doctors’ treatment decisions and increase our confidence in switching a patient from a reference biologic to an approved biosimilar therapy. As such, the ACR strongly advocates for data that are accessible on the interchangeable drug’s label via text or hyperlink. Moreover, we believe the FDA should require manufacturers to monitor the effects of biosimilars after they have been licensed for use. These data should then serve as the basis of any postmarketing labeling changes.

  • The ACR supports the FDA’s plan to use distinguishable and meaningful suffixes, which would help minimize the inadvertent or inappropriate substitution of biosimilars that have not been determined to be interchangeable. Distinct, memorable names and clear labeling is critical to decrease substitution errors and ensure pharmacovigilance. That’s why we believe the FDA can take even further steps to ensure clear labeling practices.

Detailed labeling and dispensing guidance would help ensure that a drug’s status of interchangeability is visible to both doctor and patient. The ACR recommends that:

  1. Each biosimilar label indicate not only whether a drug is biosimilar but also if it is interchangeable
  2. Clinical data for biosimilars be included on FDA labels
  3. Specific guidance be adopted to prevent the inadvertent substitution of a non-interchangeable biosimilar.

These steps would ensure that physicians and patients are fully informed.

The ACR is eager to see the draft interchangeability guidance finalized and that the FDA is given additional resources to hire experts, issue additional guidance, and expedite the review and approval of new biosimilar drugs. By continuing to emphasize safety and efficacy, the FDA will ensure that US patients reap the many benefits of biosimilars.

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