Commonsense State Rules Ease Access to Biosimilars

August 11, 2021

Health care in the United States has quietly turned a big corner. Just as the FDA approved its first interchangeable biosimilar, Oklahoma became the 50th and final state where pharmacists can substitute these lower-cost versions of biologic drugs.  

Highly effective but often expensive, biologics are sophisticated drugs credited with dramatic progress in treating rheumatoid arthritis, cancer, diabetes, multiple sclerosis and other conditions. In every state, pharmacists can now substitute interchangeable biosimilar drugs after the patent for the original biologic drug expires.

This nationwide flexibility could eventually produce health and cost benefits on the same scale that generic prescriptions have offered for conventional drugs.

Biologics & Biosimilars

Unlike conventional drugs, biologics are not chemically synthesized. There are slight differences between even batches of the same biologic, which makes exact duplication impossible. Biosimilars have, however, been deemed by the FDA as having no clinically meaningful differences from their “reference product” – the original biologic.

They also offer the potential for cost savings. Since the first biosimilar was approved by the FDA in 2015, these drugs have launched at prices 15% to 35% lower than biologic reference products.  

Interchangeable biosimilars, the drugs now approved for substitution, are a subclass of biosimilars proven to produce the same clinical results as their reference products for any given patient. To be approved as interchangeable by the FDA, they must also prove capable of being switched with the reference product, sometimes repeatedly.

Treatment Options & Patient-Centered Care

The state rules now in place will no doubt encourage the growth of biosimilars and interchangeable biosimilars. That will, in turn, expand the range of treatment options available to patients and providers.

But will pharmacy substitution undermine patients and providers’ decisions about treatment? Not necessarily.

Most states require that prescribing physicians and patients be notified of any substitution made at the pharmacy. And, by limiting substitution to interchangeable biosimilars, the laws aim to ensure that patients still receive the full benefit of the originally prescribed biologic.

By balancing access with patient protections, commonsense policy on biosimilar substitution makes the life-changing benefits of biologic medicine as accessible and affordable as possible.

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