State Biosimilar Substitution Laws May Limit Consumer Access and Retention | So Good News


Biologicals, or biologics, are used to treat a variety of diseases that often affect the elderly such as cancer, multiple sclerosis, and rheumatoid arthritis. Unlike traditional medicines that are derived from drugs, biologics are made from living cells. They are also expensive: many of the most commonly used biologics have annual prices that exceed $30,000 per year.

In the United States, spending on biologics is now 10 times higher than conventional medicine. Meanwhile, products that represent half of the money spent today may face or will soon face competition from biosimilars, which are cheaper but safer and more effective alternatives to natural medicines. These trends indicate that consumers and payers may see significant savings from increased use of biosimilars.

However, while patients facing high prescription drug costs often find more savings when switching from generic to generic drugs, this approach is not yet widely available for natural medicine. State regulations for biosimilar replacements may stand in the way.

State Laws Control How Pharmacists Prescribe Drugs

Over the past decade, every state in the US and the District of Columbia have enacted legislation banning the substitution of biosimilars and modified biosimilars, the Food and Drug Administration’s (FDA) designation for a biosimilar that produces the same clinical results as the original biologic drug. In many cases these laws were controversial, because they often include other requirements that do not work in traditional alternatives, despite the fact that there is a lot of clinical evidence that biosimilars are safe and effective.

Proponents of increased biosimilar requirements instead argued that increased regulation would protect patient safety and patient-patient relationships and reduce the potential for drug overdoses. Many of these arguments reflect concerns that have been raised in the past about changes in traditional medicine that turned out to be unfounded.

Some stakeholders suggested that alternative medicines could create barriers that limit generic substitution and that other restrictions could also limit the use and retention of biosimilars. The FDA and the US Federal Trade Commission have also reported this.

Different Biosimilar Substitution Treatments

State substitute drug laws distinguish between generic drugs and biosimilars in a number of ways:

  • Forty-seven states and the District of Columbia require pharmacists to notify the prescriber when they are prescribing a modified biosimilar, usually within a specified time frame and using specific procedures. In contrast, only two countries have similar requirements rather than traditional ones.
  • Twenty-nine states and the District of Columbia require pharmacists to inform or obtain consent from patients before substituting a generic for a brand name. However, 40 states and the District of Columbia require such information for modified biosimilars.
  • Thirteen states require pharmacists to keep written or electronic records of any modified biosimilar or natural product that is dispensed for a specified period of time. There are no formal government requirements for traditional succession.
  • Although 18 state laws include mandatory substitution of generic drugs, only 12 states require substitution of generic biosimilars.

The end

Inexpensive generic drugs are associated with better compliance and health outcomes, and generic substitution is a popular way to provide generics with competitive pricing. As such, low-cost biosimilars can help reduce out-of-pocket costs and, thereby, improve patient adherence and health outcomes and reduce overall health care costs.

The biosimilar market will not be able to deliver such benefits if the biosimilar revolution is unduly forced. Differences in state substitution laws can create concerns about biosimilars and unnecessarily limit the opportunity to purchase and save money from these important products.

Relevant Words:
Purvis, Leigh, and James McSpadden. State Biosimilar Substitution Laws May Limit Consumer Access and Money. Washington, DC: AARP Public Policy Institute, October 26, 2022.


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