Alec Stone
Alec Stone MA, MPA, ONS Public Affairs Director

Options and cost are a double-edged sword as biomedical research marches forward and the list of approved drugs expands. More targeted drugs for specific diseases means that more patients have treatment plans that can directly fight their specific disease, possibly resulting in cures.

In 1984, the U.S. Congress passed a bill called the Drug Price Competition and Patent Term Restoration Act, commonly known as Hatch-Waxman. Its goal was to “revise the procedures for new drug applications and . . . to authorize the extension of the patents for certain regulated products.” As in all things regulatory, the interpretation and implementation of the law continues to evolve, 35 years after the legislation was enacted.

Since then, new U.S. Food and Drug Administration (FDA) approvals for generic and biosimilar drugs have opened an entirely new realm of treatment plans. However, as ONS’s statement on drug shortages as a public health issue points out, “prescription medications are often not as readily available as patients and providers are led to believe.” Oncology nurses see how drug shortages and the high costs of those same cancer drugs have an impact on treatment plans.

How Laws Affect Biosimilar Approvals

As drugs that a similar, but not identical to their reference products, biosimilars can often be clinically and cost effective in patients’ treatment plans. The FDA cites the drugs as “biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product.” Oncology nurses are aware that biosimilars, although safe and effective, must be monitored and managed for each individual patient. Symptom management education continues to be a priority in care.

The U.S. Congress is frequently revisiting oversight and approval laws such as Hatch-Waxman. In 2009, it passed in the Biologics Price Competition and Innovation Act to streamline regulatory authority pathways for drug approval. The law has five elements:

  • The biologic must be biosimilar to a reference product, where the reference product is a biologic previously approved by the FDA.
  • The biologic product and reference product must use the same mechanism or mechanisms of action.
  • The conditions of use prescribed, recommended, or suggested in the biological product’s labeling must have been previously approved for the reference product.
  • The route of administration, dosage form, and strength of the biological product must be the same as those of the reference product.
  • The manufacturing facility must meet standards designed to ensure safety, purity, and potency.

How the FDA Supports Providers

To help providers ensure safe and effective treatment options for patients, the FDA maintains a list of guidelines and references in the following categories:

  • Biosimilar and interchangeable products
  • Biosimilar development, review, and approval
  • Industry information and guidance
  • Online courses, webinars, and presentations
  • Patient and prescriber outreach materials

Where We Go From Here

According to the National Cancer for Biotechnology Information, a division of the National Institutes of Health, “This has created the opportunity for the development and approval of biosimilars.” This is a complex and evolving conversation, as the field of biologics is moving at breakneck speed. Risk and reward seem to go hand and hand in this area, and no end is in sight for how it will transform health care.

Such discoveries are changing our understanding of cancer and patient-centered care, pillars of ONS’s policy priorities. Oncology nurses are an integral part of coordinated care and ensuring quality treatment for patients.

To learn how you can lend your voice to the conversation, contact