GPhA and Biosimilars Council Praise New State Laws to Allow Automatic Substitution for Interchangeable Biologics


Five states join roster of those pioneering patient access to new medicines.


WASHINGTON, DC (May 13, 2015) — The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council today applaud the enactment of legislation in five states to allow automatic substitution for Food and Drug Administration (FDA) approved interchangeable biologic products.

Bills in Colorado (SB 71), Georgia (SB 51), Tennessee (SB 984), Utah (HB 279) and Washington (SB 5935) reflect core principles embraced in language agreed upon by GPhA and a wide coalition of brand manufacturers, Express Scripts, and others.

“GPhA and the Biosimilars Council commend Colorado, Georgia, Tennessee, Utah and Washington for passing laws that create a competitive market for biosimilar products and provide patient access to affordable versions of these critical medicines,” said Ralph G. Neas, President and CEO, GPhA. “We are pleased these states have embraced a framework for these new medicines that reflects our organizations’ core principles: uphold the current pharmacy practice of automatic substitution; rely on the science-based determination of interchangeability by the Food and Drug Administration (FDA); and treat interchangeables and their corresponding brand biologics the same during dispensing at the pharmacy.”

As biosimilars become available in the United States, states likely will pursue legislation that governs automatic substitution of biological products that the FDA deems interchangeable.

Since 2012, state substitution legislation has evolved significantly and continues to be introduced across the country. The GPhA position has not changed: the association strongly opposes legislation that includes mandatory prescriber notification requirements which could undermine confidence in the safety and effectiveness of biosimilars. Importantly, in the laws passed in these five states, communication would occur whether an originator biologic or an interchangeable biologic is dispensed, providing a level, competitive playing field for all of these medicines.

Notification, which GPhA opposes, is an alert before the medication is dispensed that a biosimilar or interchangeable biologic will be substituted for a brand biologic. Conversely, communication, a practice favored by GPhA and the broad coalition in support of last year’s compromise, takes place once the drug is dispensed and usually occurs automatically through electronic records, giving patients and providers comfort without altering existing pharmacy practice.

“The GPhA Biosimilars Council looks forward to working with state legislatures, supply chain participants, stakeholders, patients and others to expedite access to safe and effective biosimilar medicines,” said Neas.

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