Biosimilar and Interchangeable Products: Massachusetts Enacts New Law

Biosimilar drugs are biological drugs that are similar but not identical to a referenced biological or branded product. Approximately four years ago, Congress passed the “Biologics Price Competition and Innovation Act” (BCPIA) which granted the Food and Drug Administration (FDA) a pathway for approval of biological products that are interchangeable with a referenced or branded product.

Under the BPCIA, a product is interchangeable with a referenced product if:

  1. The biosimilar product is expected to produce the same clinical result as the reference product in any given patients; and
  2. Switching between the reference product and the biosimilar product does not increase the safety risk or reduce effectiveness.

Since the enactment of the BPCIA, the FDA has not approved an interchangeable biosimilar, but the FDA expects many companies to submit biosimilar applications in the near future as many biological medication patents are set to expire over the next two to five years.

Late last month, Massachusetts became just the seventh state to pass biosimilar legislation when the Massachusetts Governor proactively signed into law House Bill 3734, “An Act Relative to the Substitution of Interchangeable Biosimilars” (Bill 3734).  Bill 3734 authorizes pharmacists to substitute interchangeable biological products when filling a prescription for brand biological products so long as the substitution complies with the five following requirements:

  1. Pharmacists may only substitute biosimilars that the FDA has determined to be interchangeable with the prescribed product;
  2. Prescribing doctors retain “dispense as written” (DAW) authority;
  3. Pharmacists must notify prescribing doctors of biosimilar substitutions;
  4. Pharmacists must notify patients of biosimilar substitutions; and
  5. Pharmacists must retain records of biosimilar substitutions for a year.

Overall, the expectation is that once interchangeable biological products become available, they will be used interchangeably with branded biologicals and the legislation set forth will allow for a much smoother transition as pharmacists are already familiar with the process of substituting generics for brand name medications when applicable and appropriate.