Biosimilar Bill Introduced in Georgia State Senate

A proposed bill allowing biosimilar substitution in Georgia mirrors the state's generic drug substitution regulations.

A proposed bill allowing biosimilar substitution in Georgia mirrors the state’s generic drug substitution regulations.

Georgia is the latest state legislature to introduce a bill allowing biosimilar substitution.

The bill, SB 370, was filed on February 10 by state senator and pharmacist Buddy Carter, RPh, and introduced and referred to committee on February 11. It amends sections of the Official Code of Georgia to define biologic products, as well as the conventions for substituting them.

The bill focuses on pharmacists’ therapeutic knowledge, allowing a pharmacist to substitute interchangeable biologic products with the same administration, dosage form, and strength as the reference biologic, providing that the pharmacist believes the products are therapeutically equivalent. In addition, the bill requires pharmacists to dispense the biologic product with the lowest retail price that is in stock, also providing that the pharmacist believes it to be therapeutically equivalent to the prescribed product.

The bill, as introduced, defines biologic product as any “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide) or analogous product, or arsphenamine, derivative of arsphenamine, or any other trivalent organic arsenic compound applicable to the prevention, treatment, or cure of a disease or condition of human beings.” Meanwhile, it specifies that interchangeable biologic products include biologic products that meet FDA safety standards and may be substituted for a reference biologic without notifying the prescribing provider.

Although the bill does not require pharmacists to notify prescribers about the switch—a provision that appeared in bills passed in other states and is regarded as “limiting” by the Generic Pharmaceutical Association (GPhA)—pharmacists would need to note the substitution on the original prescription and to record the name and manufacturer of the dispensed product. The state has the same requirement for dispensing generic medications.

Also similar to the state’s existing generic drug substitution regulations, biosimilar products must be dispensed with a label indicating the brand name biologic product and additional language noting the substitution. As with the provision’s generic drug counterpart, medications dispensed during in-patient hospital services would be exempt from the labeling requirement.

The bill maintains patients’ and prescribers’ ability to request brand name products rather than biosimilars, another provision that is akin to the state’s generic drug laws.

The GPhA voiced its support of the proposed legislation, noting its close association with existing generic drug laws and its lack of onerous restrictions.

“While there is no ‘one-size-fits-all’ model for states, one can look to the law enacted in Florida [in 2013], and now, the bill under discussion in Georgia,” GPhA President and CEO Ralph G. Neas said in a February 11, 2014, press release. “GPhA applauds efforts in Georgia to foster timely access to interchangeable biologics. This bill takes appropriate steps to limit roadblocks to these medicines and avoids unneeded mandates for notifying physicians that extend beyond current practice.”

The bill will undergo scrutiny by a senate committee, which will then report on the bill, according to Georgia’s General Assembly website. Once in committee, it will be read and subject to committee action. Those actions can include a recommendation or resolution to pass the bill without any changes, a recommendation against passing the bill, a recommendation to pass the bill with changes, or a decision to hold the bill. If passed by committee, the bill will be subject to floor debate, amendments, and voting by the full state senate, and, if passed, will go to the legislature’s other house. If the second chamber of the legislature passes the bill, it will be printed and may be sent to the governor, if that is requested. In cases in which a copy of the bill is sent to the governor, it is considered enacted unless the governor vetoes it. In order to override a veto, a two-thirds majority vote is required in both legislative houses.